Science.gov

Sample records for 2012-04-01 false medical

  1. 21 CFR 880.6280 - Medical insole.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical insole. 880.6280 Section 880.6280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES....6280 Medical insole. (a) Identification. A medical insole is a device intended for medical...

  2. 21 CFR 880.6991 - Medical washer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical washer. 880.6991 Section 880.6991 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES....6991 Medical washer. (a) Identification. A medical washer is a device that is intended for...

  3. 22 CFR 42.66 - Medical examination.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Medical examination. 42.66 Section 42.66... NATIONALITY ACT, AS AMENDED Application for Immigrant Visas § 42.66 Medical examination. (a) Medical... require every alien, regardless of age, to undergo a medical examination in order to determine...

  4. 20 CFR 10.335 - How are medical bills submitted?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false How are medical bills submitted? 10.335... AMENDED Medical and Related Benefits Medical Bills § 10.335 How are medical bills submitted? Usually, medical providers submit bills directly to OWCP or to a bill processing agent designated by OWCP....

  5. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image digitizer. 892.2030 Section 892.2030...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a...

  6. 20 CFR 702.401 - Medical care defined.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Medical care defined. 702.401 Section 702.401... WORKERS' COMPENSATION ACT AND RELATED STATUTES ADMINISTRATION AND PROCEDURE Medical Care and Supervision § 702.401 Medical care defined. (a) Medical care shall include medical, surgical, and other...

  7. 21 CFR 880.6430 - Liquid medication dispenser.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Liquid medication dispenser. 880.6430 Section 880... Devices § 880.6430 Liquid medication dispenser. (a) Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication....

  8. 22 CFR 41.108 - Medical examination.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Medical examination. 41.108 Section 41.108... AND NATIONALITY ACT, AS AMENDED Application for Nonimmigrant Visa § 41.108 Medical examination. (a) Requirements for medical examination. An applicant for a nonimmigrant visa shall be required to take a...

  9. 21 CFR 880.6710 - Medical ultraviolet water purifier.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical ultraviolet water purifier. 880.6710... Miscellaneous Devices § 880.6710 Medical ultraviolet water purifier. (a) Identification. A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water...

  10. 21 CFR 880.5045 - Medical recirculating air cleaner.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical recirculating air cleaner. 880.5045... Therapeutic Devices § 880.5045 Medical recirculating air cleaner. (a) Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device...

  11. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  12. 21 CFR 892.5300 - Medical neutron radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical neutron radiation therapy system. 892.5300... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron radiation therapy system. (a) Identification. A medical neutron radiation therapy system is a device intended...

  13. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  14. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  15. 21 CFR 880.6315 - Remote Medication Management System.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Remote Medication Management System. 880.6315... Miscellaneous Devices § 880.6315 Remote Medication Management System. (a) Identification. A remote medication management system is a device composed of clinical and communications software, a medication delivery...

  16. 20 CFR 725.708 - Disputes concerning medical benefits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Disputes concerning medical benefits. 725.708... FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED Medical Benefits and Vocational Rehabilitation § 725.708 Disputes concerning medical benefits. (a) Whenever a dispute develops concerning medical services...

  17. 21 CFR 558.5 - Requirements for liquid medicated feed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Requirements for liquid medicated feed. 558.5... Provisions § 558.5 Requirements for liquid medicated feed. (a) What types of liquid medicated feeds are covered by this section? This section covers the following types of liquid medicated feed: (1) Type B...

  18. 20 CFR 30.420 - How should medical bills and reimbursement requests be submitted?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false How should medical bills and reimbursement... Medical and Related Benefits Medical Bills § 30.420 How should medical bills and reimbursement requests be submitted? Usually, medical providers submit their bills directly for processing. The rules for...

  19. 20 CFR 61.204 - Furnishing of medical treatment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Furnishing of medical treatment. 61.204..., Disability or Death § 61.204 Furnishing of medical treatment. All medical services, appliances, drugs and... the same manner and under the same regulations, as are prescribed for the furnishing of...

  20. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  1. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices;...

  2. 21 CFR 880.6500 - Medical ultraviolet air purifier.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... to ultraviolet radiation. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical ultraviolet air purifier. 880.6500 Section... Miscellaneous Devices § 880.6500 Medical ultraviolet air purifier. (a) Identification. A medical ultraviolet...

  3. 20 CFR 725.705 - Arrangements for medical care.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Arrangements for medical care. 725.705... FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED Medical Benefits and Vocational Rehabilitation § 725.705 Arrangements for medical care. (a) Operator liability. If an operator has been determined liable for...

  4. 20 CFR 702.407 - Supervision of medical care.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Supervision of medical care. 702.407 Section...'S AND HARBOR WORKERS' COMPENSATION ACT AND RELATED STATUTES ADMINISTRATION AND PROCEDURE Medical Care and Supervision § 702.407 Supervision of medical care. The Director, OWCP, through the...

  5. 21 CFR 640.62 - Medical supervision.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Medical supervision. 640.62 Section 640.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.62 Medical supervision....

  6. 20 CFR 404.1526 - Medical equivalence.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Medical equivalence. 404.1526 Section 404.1526 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Medical Considerations § 404.1526...

  7. 21 CFR 21.33 - Medical records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Medical records. 21.33 Section 21.33 Food and... PRIVACY Requirements for Specific Categories of Records § 21.33 Medical records. (a) In general, an... in lieu of the procedures in paragraph (b)(1), that are not inconsistent with § 21.41(f)....

  8. 21 CFR 880.5240 - Medical adhesive tape and adhesive bandage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical adhesive tape and adhesive bandage. 880... Personal Use Therapeutic Devices § 880.5240 Medical adhesive tape and adhesive bandage. (a) Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that...

  9. 20 CFR 10.801 - How are medical bills to be submitted?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false How are medical bills to be submitted? 10.801... AMENDED Information for Medical Providers Medical Records and Bills § 10.801 How are medical bills to be... electronic or paper-based bill that includes required data elements (for pharmacies) or other form...

  10. 20 CFR 30.701 - How are medical bills to be submitted?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false How are medical bills to be submitted? 30.701... Providers Medical Records and Bills § 30.701 How are medical bills to be submitted? (a) All charges for...), Form OWCP-04 or UB-04 (for hospitals), an electronic or paper-based bill that includes required...

  11. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices having commonly known directions... SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  12. 20 CFR 702.409 - Evaluation of medical questions; results disputed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Evaluation of medical questions; results disputed. 702.409 Section 702.409 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT... PROCEDURE Medical Care and Supervision § 702.409 Evaluation of medical questions; results disputed....

  13. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical...

  14. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; adequate directions for use. 801.5 Section 801.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate...

  15. 21 CFR 510.455 - Requirements for free-choice medicated feeds.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... specifications of the free-choice medicated feed, where the owner of this information requests such publication... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Requirements for free-choice medicated feeds. 510... New Animal Drugs § 510.455 Requirements for free-choice medicated feeds. (a) What is...

  16. 21 CFR 880.6350 - Battery-powered medical examination light.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Battery-powered medical examination light. 880... Personal Use Miscellaneous Devices § 880.6350 Battery-powered medical examination light. (a) Identification. A battery-powered medical examination light is a battery-powered device intended for...

  17. 20 CFR 220.56 - Securing medical evidence at the hearings officer hearing level.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Securing medical evidence at the hearings officer hearing level. 220.56 Section 220.56 Employees' Benefits RAILROAD RETIREMENT BOARD REGULATIONS UNDER THE RAILROAD RETIREMENT ACT DETERMINING DISABILITY Consultative Examinations § 220.56 Securing medical evidence at the hearings officer...

  18. 22 CFR 96.49 - Provision of medical and social information in incoming cases.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., including, but not limited to any social work or court reports on the child and any information on who... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Provision of medical and social information in... United States (incoming Cases) § 96.49 Provision of medical and social information in incoming cases....

  19. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  20. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; Spanish-language version of certain required statements. 801.16 Section 801.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions §...

  1. 21 CFR 515.21 - Refusal to approve a medicated feed mill license application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Refusal to approve a medicated feed mill license application. 515.21 Section 515.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Actions on Licenses § 515.21 Refusal to approve a medicated feed mill license application. (a)...

  2. 21 CFR 870.2450 - Medical cathode-ray tube display.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical cathode-ray tube display. 870.2450 Section 870.2450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... cathode-ray tube display. (a) Identification. A medical cathode-ray tube display is a device...

  3. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; name and place of business of manufacturer, packer or distributor. 801.1 Section 801.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling...

  4. 20 CFR 10.337 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 10.337... for a medical expense, must the provider refund the balance of the amount paid to the employee?...

  5. 26 CFR 31.3121(a)(4)-1 - Payments on account of sickness or accident disability, or medical or hospitalization expenses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 26 Internal Revenue 15 2012-04-01 2012-04-01 false Payments on account of sickness or accident... account of sickness or accident disability, or medical or hospitalization expenses. The term “wages” does... employee's sickness or accident disability or the medical or hospitalization expenses in connection...

  6. 20 CFR 404.1569 - Listing of Medical-Vocational Guidelines in appendix 2.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Listing of Medical-Vocational Guidelines in appendix 2. 404.1569 Section 404.1569 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Vocational...

  7. 20 CFR 404.1516 - If you fail to submit medical and other evidence.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false If you fail to submit medical and other evidence. 404.1516 Section 404.1516 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Evidence § 404.1516 If...

  8. 20 CFR Appendix 2 to Subpart P of... - Medical-Vocational Guidelines

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Medical-Vocational Guidelines 2 Appendix 2 to Subpart P of Part 404 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Pt. 404, Subpt. P, App. 2 Appendix 2...

  9. 21 CFR 1250.84 - Water in galleys and medical care spaces.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and in connection with garbage disposal. Any tap discharging nonpotable water which is installed for... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Water in galleys and medical care spaces. 1250.84... CONVEYANCE SANITATION Sanitation Facilities and Conditions on Vessels § 1250.84 Water in galleys and...

  10. 20 CFR 702.413 - Fees for medical services; prevailing community charges.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... described in 20 CFR 10.411) to the extent appropriate, and where not appropriate, may use other state or... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Fees for medical services; prevailing community charges. 702.413 Section 702.413 Employees' Benefits OFFICE OF WORKERS' COMPENSATION...

  11. 20 CFR 702.414 - Fees for medical services; unresolved disputes on prevailing charges.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... provider or service is not one covered by the OWCP fee schedule as described by 20 CFR 10.411(d)(1). (2... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Fees for medical services; unresolved disputes on prevailing charges. 702.414 Section 702.414 Employees' Benefits OFFICE OF WORKERS'...

  12. 21 CFR 880.6260 - Filtering facepiece respirator for use by the general public in public health medical emergencies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84. (2) The... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Filtering facepiece respirator for use by the... Filtering facepiece respirator for use by the general public in public health medical emergencies....

  13. 20 CFR 416.996 - Continued disability or blindness benefits pending appeal of a medical cessation determination.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Continued disability or blindness benefits... Disability and Blindness Continuing Or Stopping Disability Or Blindness § 416.996 Continued disability or blindness benefits pending appeal of a medical cessation determination. (a) General. If we determine...

  14. 20 CFR 404.1562 - Medical-vocational profiles showing an inability to make an adjustment to other work.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Medical-vocational profiles showing an inability to make an adjustment to other work. 404.1562 Section 404.1562 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and...

  15. 20 CFR 30.422 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 30.422... provider refund the balance of the amount paid to the employee? (a) The OWCP fee schedule sets...

  16. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Where can I find the reporting codes for adverse events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG... Generally Applicable Requirements for Individual Adverse Event Reports § 803.21 Where can I find...

  17. 26 CFR 31.3121(a)(2)-1 - Payments on account of sickness or accident disability, medical or hospitalization expenses, or...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 26 Internal Revenue 15 2012-04-01 2012-04-01 false Payments on account of sickness or accident... account of sickness or accident disability, medical or hospitalization expenses, or death. (a) The term...— (1) Sickness or accident disability of an employee or any of his dependents, only if payment...

  18. 20 CFR 356.3 - False claims.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false False claims. 356.3 Section 356.3 Employees' Benefits RAILROAD RETIREMENT BOARD ADMINISTRATIVE REMEDIES FOR FRAUDULENT CLAIMS OR STATEMENTS CIVIL MONETARY PENALTY INFLATION ADJUSTMENT § 356.3 False claims. In the case of penalties assessed under 31...

  19. 22 CFR 40.63 - Misrepresentation; Falsely claiming citizenship.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Misrepresentation; Falsely claiming citizenship. 40.63 Section 40.63 Foreign Relations DEPARTMENT OF STATE VISAS REGULATIONS PERTAINING TO BOTH... Immigration Violators § 40.63 Misrepresentation; Falsely claiming citizenship. (a) Fraud and...

  20. 20 CFR 702.217 - Penalty for false statement, misrepresentation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Penalty for false statement... PROCEDURE Claims Procedures Notice § 702.217 Penalty for false statement, misrepresentation. (a) Any..., or his dependents pursuant to section 9, 33 U.S.C. 909, if the injury results in death, shall...

  1. 20 CFR 356.3 - False claims.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true False claims. 356.3 Section 356.3 Employees' Benefits RAILROAD RETIREMENT BOARD ADMINISTRATIVE REMEDIES FOR FRAUDULENT CLAIMS OR STATEMENTS CIVIL MONETARY PENALTY INFLATION ADJUSTMENT § 356.3 False claims. In the case of penalties assessed under 31...

  2. 20 CFR 356.3 - False claims.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true False claims. 356.3 Section 356.3 Employees' Benefits RAILROAD RETIREMENT BOARD ADMINISTRATIVE REMEDIES FOR FRAUDULENT CLAIMS OR STATEMENTS CIVIL MONETARY PENALTY INFLATION ADJUSTMENT § 356.3 False claims. In the case of penalties assessed under 31...

  3. 20 CFR 404.1597a - Continued benefits pending appeal of a medical cessation determination.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Continued benefits pending appeal of a... administrative law judge is pending on that date). (2) Benefits may be continued under this section only for... entitlement to benefits based on disability), pending the outcome of your appeal. (2) If anyone else...

  4. The false claims act and its impact on medical practices.

    PubMed

    Vogel, Robert L

    2010-01-01

    A lawsuit under the federal False Claims Act can threaten the survival of a medical practice. The Act prohibits a range of misconduct involving the submission of false claims to the government, as well as the knowing and improper retention of overpayments of government funds. Violations of the Act result in liability for treble damages and civil penalties of as much as $11,000 per violation. Although the Act imposes liability only on persons who act "knowingly," the "knowing" requirement is met if the person acts with deliberate ignorance or reckless disregard of the circumstances. The Act contains a "qui tam provision under which a whistleblower, acting on behalf of the government, may file suit to enforce the Act's terms, and if the lawsuit is successful, can receive a substantial percentage of the government's recovery.

  5. 25 CFR 900.201 - How should claims arising out of the performance of medical-related functions be filed?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... THE INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE ACT Federal Tort Claims Act Coverage General... monetary damage claimed) with the Office of the General Counsel, General Law Division, Claims Office, 330... 25 Indians 2 2012-04-01 2012-04-01 false How should claims arising out of the performance...

  6. 20 CFR 404.1051 - Payments on account of sickness or accident disability, or related medical or hospitalization...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Payments on account of sickness or accident..., Wages, Self-Employment, and Self-Employment Income Wages § 404.1051 Payments on account of sickness or... payment that an employer makes to you, or on your behalf, on account of your sickness or...

  7. 26 CFR 31.3306(b)(4)-1 - Payments on account of sickness or accident disability, or medical or hospitalization expenses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 26 Internal Revenue 15 2012-04-01 2012-04-01 false Payments on account of sickness or accident... (Chapter 23, Internal Revenue Code of 1954) § 31.3306(b)(4)-1 Payments on account of sickness or accident... employer to, or on behalf of, an employee on account of the employee's sickness or accident disability...

  8. 21 CFR 884.6150 - Assisted reproduction micromanipulators and microinjectors.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Assisted reproduction micromanipulators and... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Assisted Reproduction Devices § 884.6150 Assisted reproduction micromanipulators and microinjectors. (a)...

  9. 21 CFR 884.6140 - Assisted reproduction micropipette fabrication instruments.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Assisted reproduction micropipette fabrication... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Assisted Reproduction Devices § 884.6140 Assisted reproduction micropipette fabrication instruments. (a)...

  10. 20 CFR 220.46 - Medical evidence.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true Medical evidence. 220.46 Section 220.46... DISABILITY Evidence of Disability § 220.46 Medical evidence. (a) Acceptable sources. The Board needs reports about the claimant's impairment(s) from acceptable medical sources. Acceptable medical sources are—...

  11. 20 CFR 10.335 - How are medical bills submitted?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true How are medical bills submitted? 10.335... AMENDED Medical and Related Benefits Medical Bills § 10.335 How are medical bills submitted? Usually, medical providers submit bills directly to OWCP or to a bill processing agent designated by OWCP....

  12. 20 CFR 10.335 - How are medical bills submitted?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true How are medical bills submitted? 10.335... AMENDED Medical and Related Benefits Medical Bills § 10.335 How are medical bills submitted? Usually, medical providers submit bills directly to OWCP or to a bill processing agent designated by OWCP....

  13. 25 CFR 11.1014 - Medical examination.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 1 2012-04-01 2011-04-01 true Medical examination. 11.1014 Section 11.1014 Indians... ORDER CODE Juvenile Offender Procedure § 11.1014 Medical examination. The children's court may order a medical examination for a minor who is alleged to be a juvenile offender....

  14. 22 CFR 505.6 - Medical records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 2 2012-04-01 2009-04-01 true Medical records. 505.6 Section 505.6 Foreign Relations BROADCASTING BOARD OF GOVERNORS PRIVACY ACT REGULATION § 505.6 Medical records. If, in the judgment of the Agency, the release of medical information to you could have an adverse effect, the...

  15. 20 CFR 30.420 - How should medical bills and reimbursement requests be submitted?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true How should medical bills and reimbursement... Medical and Related Benefits Medical Bills § 30.420 How should medical bills and reimbursement requests be submitted? Usually, medical providers submit their bills directly for processing. The rules for...

  16. 20 CFR 30.420 - How should medical bills and reimbursement requests be submitted?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true How should medical bills and reimbursement... Medical and Related Benefits Medical Bills § 30.420 How should medical bills and reimbursement requests be submitted? Usually, medical providers submit their bills directly for processing. The rules for...

  17. 20 CFR 61.204 - Furnishing of medical treatment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true Furnishing of medical treatment. 61.204..., Disability or Death § 61.204 Furnishing of medical treatment. All medical services, appliances, drugs and... the same manner and under the same regulations, as are prescribed for the furnishing of...

  18. 20 CFR 61.204 - Furnishing of medical treatment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true Furnishing of medical treatment. 61.204..., Disability or Death § 61.204 Furnishing of medical treatment. All medical services, appliances, drugs and supplies which in the opinion of the Office are necessary for the treatment of an injury coming within...

  19. 20 CFR 10.801 - How are medical bills to be submitted?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true How are medical bills to be submitted? 10.801... AMENDED Information for Medical Providers Medical Records and Bills § 10.801 How are medical bills to be... electronic or paper-based bill that includes required data elements (for pharmacies) or other form...

  20. 20 CFR 10.801 - How are medical bills to be submitted?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true How are medical bills to be submitted? 10.801... AMENDED Information for Medical Providers Medical Records and Bills § 10.801 How are medical bills to be... electronic or paper-based bill that includes required data elements (for pharmacies) or other form...

  1. 20 CFR 30.701 - How are medical bills to be submitted?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true How are medical bills to be submitted? 30.701... Providers Medical Records and Bills § 30.701 How are medical bills to be submitted? (a) All charges for...), Form OWCP-04 or UB-04 (for hospitals), an electronic or paper-based bill that includes required...

  2. 20 CFR 30.701 - How are medical bills to be submitted?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true How are medical bills to be submitted? 30.701... Providers Medical Records and Bills § 30.701 How are medical bills to be submitted? (a) All charges for...), Form OWCP-04 or UB-04 (for hospitals), an electronic or paper-based bill that includes required...

  3. An estimate of the science-wise false discovery rate and application to the top medical literature.

    PubMed

    Jager, Leah R; Leek, Jeffrey T

    2014-01-01

    The accuracy of published medical research is critical for scientists, physicians and patients who rely on these results. However, the fundamental belief in the medical literature was called into serious question by a paper suggesting that most published medical research is false. Here we adapt estimation methods from the genomics community to the problem of estimating the rate of false discoveries in the medical literature using reported $P$-values as the data. We then collect $P$-values from the abstracts of all 77 430 papers published in The Lancet, The Journal of the American Medical Association, The New England Journal of Medicine, The British Medical Journal, and The American Journal of Epidemiology between 2000 and 2010. Among these papers, we found 5322 reported $P$-values. We estimate that the overall rate of false discoveries among reported results is 14% (s.d. 1%), contrary to previous claims. We also found that there is no a significant increase in the estimated rate of reported false discovery results over time (0.5% more false positives (FP) per year, $P = 0.18$) or with respect to journal submissions (0.5% more FP per 100 submissions, $P = 0.12$). Statistical analysis must allow for false discoveries in order to make claims on the basis of noisy data. But our analysis suggests that the medical literature remains a reliable record of scientific progress.

  4. 26 CFR 1.401-14 - Inclusion of medical benefits for retired employees in qualified pension or annuity plans.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 26 Internal Revenue 5 2012-04-01 2011-04-01 true Inclusion of medical benefits for retired employees in qualified pension or annuity plans. 1.401-14 Section 1.401-14 Internal Revenue INTERNAL REVENUE..., Profit-Sharing, Stock Bonus Plans, Etc. § 1.401-14 Inclusion of medical benefits for retired employees...

  5. Discussion: Why "An estimate of the science-wise false discovery rate and application to the top medical literature" is false.

    PubMed

    Ioannidis, John P A

    2014-01-01

    Jager and Leek have tried to estimate a false-discovery rate (FDR) in abstracts of articles published in five medical journals during 2000-2010. Their approach is flawed in sampling, calculations, and conclusions. It uses a tiny portion of select papers in highly select journals. Randomized controlled trials and systematic reviews (designs with the lowest anticipated false-positive rates) are 52% of the analyzed papers, while these designs account for only 4% in PubMed in the same period. The FDR calculations consider the entire published literature as equivalent to a single genomic experiment where all performed analyses are reported without selection or distortion. However, the data used are the P-values reported in the abstracts of published papers; these P-values are a highly distorted, highly select sample. Besides selective reporting biases, all other biases, in particular confounding in observational studies, are also ignored, while these are often the main drivers for high false-positive rates in the biomedical literature. A reproducibility check of the raw data shows that much of the data Jager and Leek used are either wrong or make no sense: most of the usable data were missed by their script, 94% of the abstracts that reported ≥2 P-values had high correlation/overlap between reported outcomes, and only a minority of P-values corresponded to relevant primary outcomes. The Jager and Leek paper exemplifies the dreadful combination of using automated scripts with wrong methods and unreliable data. Sadly, this combination is common in the medical literature.

  6. 20 CFR 10.337 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 10.337... for a medical expense, must the provider refund the balance of the amount paid to the employee?...

  7. 20 CFR 10.337 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 10.337... for a medical expense, must the provider refund the balance of the amount paid to the employee?...

  8. 20 CFR 30.422 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 30.422... provider refund the balance of the amount paid to the employee? (a) The OWCP fee schedule sets...

  9. 21 CFR 868.2900 - Gas pressure transducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas pressure transducer. 868.2900 Section 868.2900...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2900 Gas pressure transducer. (a) Identification. A gas pressure transducer is a device intended for medical purposes that is used to convert...

  10. 21 CFR 868.2620 - Gas pressure calibrator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas pressure calibrator. 868.2620 Section 868.2620...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2620 Gas pressure calibrator. (a) Identification. A gas pressure calibrator is a device intended for medical purposes that is used to...

  11. 20 CFR 30.412 - Who pays for second opinion and referee examinations?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Who pays for second opinion and referee... Related Benefits Directed Medical Examinations § 30.412 Who pays for second opinion and referee examinations? OWCP will pay second opinion and referee medical specialists directly. OWCP will also...

  12. 21 CFR 868.6250 - Portable air compressor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Portable air compressor. 868.6250 Section 868.6250...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6250 Portable air compressor. (a) Identification. A portable air compressor is a device intended to provide compressed air for medical purposes,...

  13. 20 CFR 10.336 - What are the time frames for submitting bills?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false What are the time frames for submitting bills...' COMPENSATION ACT, AS AMENDED Medical and Related Benefits Medical Bills § 10.336 What are the time frames for submitting bills? To be considered for payment, bills must be submitted by the end of the calendar year...

  14. 20 CFR 30.421 - What are the time frames for submitting bills and reimbursement requests?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false What are the time frames for submitting bills... AMENDED Medical and Related Benefits Medical Bills § 30.421 What are the time frames for submitting bills and reimbursement requests? To be considered for payment, bills and reimbursement requests must...

  15. 21 CFR 814.120 - Temporary suspension of approval of an HDE.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Temporary suspension of approval of an HDE. 814.120 Section 814.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices §...

  16. 21 CFR 814.40 - Time frames for reviewing a PMA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Time frames for reviewing a PMA. 814.40 Section 814.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.40 Time frames...

  17. 21 CFR 814.114 - Timeframes for reviewing an HDE.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Timeframes for reviewing an HDE. 814.114 Section 814.114 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices §...

  18. 21 CFR 814.17 - Service of orders.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Service of orders. 814.17 Section 814.17 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.17 Service of orders. Orders issued under this part...

  19. 21 CFR 814.110 - New indications for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false New indications for use. 814.110 Section 814.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.110 New...

  20. 21 CFR 814.106 - HDE amendments and resubmitted HDE's.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false HDE amendments and resubmitted HDE's. 814.106 Section 814.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.106...

  1. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  2. 21 CFR 814.122 - Confidentiality of data and information.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Confidentiality of data and information. 814.122 Section 814.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices §...

  3. 21 CFR 801.421 - Hearing aid devices; conditions for sale.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the patient's hearing loss has been medically evaluated and the patient may be considered a candidate... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hearing aid devices; conditions for sale. 801.421... (CONTINUED) MEDICAL DEVICES LABELING Special Requirements for Specific Devices § 801.421 Hearing aid...

  4. 21 CFR 868.5310 - Carbon dioxide absorber.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carbon dioxide absorber. 868.5310 Section 868.5310...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5310 Carbon dioxide absorber. (a) Identification. A carbon dioxide absorber is a device that is intended for medical purposes and that is used in...

  5. 21 CFR 868.5300 - Carbon dioxide absorbent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carbon dioxide absorbent. 868.5300 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5300 Carbon dioxide absorbent. (a) Identification. A carbon dioxide absorbent is a device intended for medical purposes that consists of...

  6. 21 CFR 808.85 - Ohio.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ohio. 808.85 Section 808.85 Food and Drugs FOOD... EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific State and Local Exemptions § 808.85 Ohio. (a) The following Ohio medical device requirement is...

  7. 21 CFR 808.98 - West Virginia.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false West Virginia. 808.98 Section 808.98 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  8. 21 CFR 808.61 - Hawaii.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hawaii. 808.61 Section 808.61 Food and Drugs FOOD... EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific State and Local Exemptions § 808.61 Hawaii. (a) The following Hawaii medical device requirements...

  9. 21 CFR 808.81 - New Mexico.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false New Mexico. 808.81 Section 808.81 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  10. 21 CFR 808.20 - Application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Application. 808.20 Section 808.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Exemption Procedures §...

  11. 21 CFR 808.67 - Kentucky.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Kentucky. 808.67 Section 808.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  12. 21 CFR 808.74 - Mississippi.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mississippi. 808.74 Section 808.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  13. 21 CFR 808.80 - New Jersey.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false New Jersey. 808.80 Section 808.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  14. 21 CFR 808.77 - Nebraska.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nebraska. 808.77 Section 808.77 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  15. 21 CFR 808.25 - Procedures for processing an application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Procedures for processing an application. 808.25 Section 808.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE...

  16. 21 CFR 808.57 - Connecticut.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Connecticut. 808.57 Section 808.57 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  17. 21 CFR 808.55 - California.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false California. 808.55 Section 808.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  18. 21 CFR 808.101 - District of Columbia.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false District of Columbia. 808.101 Section 808.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing...

  19. 21 CFR 808.88 - Pennsylvania.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pennsylvania. 808.88 Section 808.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  20. 21 CFR 808.59 - Florida.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Florida. 808.59 Section 808.59 Food and Drugs FOOD... EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific State and Local Exemptions § 808.59 Florida. The following Florida medical device requirements are...

  1. 21 CFR 808.5 - Advisory opinions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Advisory opinions. 808.5 Section 808.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS General Provisions §...

  2. 21 CFR 808.53 - Arizona.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Arizona. 808.53 Section 808.53 Food and Drugs FOOD... EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific State and Local Exemptions § 808.53 Arizona. The following Arizona medical device requirements are...

  3. 21 CFR 808.87 - Oregon.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oregon. 808.87 Section 808.87 Food and Drugs FOOD... EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific State and Local Exemptions § 808.87 Oregon. (a) The following Oregon medical device requriements...

  4. 21 CFR 808.82 - New York.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false New York. 808.82 Section 808.82 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  5. 21 CFR 808.93 - Texas.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Texas. 808.93 Section 808.93 Food and Drugs FOOD... EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific State and Local Exemptions § 808.93 Texas. (a) The following Texas medical device requirement is...

  6. 21 CFR 808.97 - Washington.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Washington. 808.97 Section 808.97 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  7. 21 CFR 808.35 - Revocation of an exemption.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Revocation of an exemption. 808.35 Section 808.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE...

  8. 21 CFR 808.71 - Massachusetts.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Massachusetts. 808.71 Section 808.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific...

  9. 21 CFR 808.69 - Maine.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Maine. 808.69 Section 808.69 Food and Drugs FOOD... EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific State and Local Exemptions § 808.69 Maine. (a) The following Maine medical device requirement is...

  10. 21 CFR 870.3460 - Endovascular Suturing System.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endovascular Suturing System. 870.3460 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3460 Endovascular Suturing System. (a) Identification. An endovascular suturing system is a medical device intended to...

  11. 21 CFR 810.13 - Mandatory recall order.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mandatory recall order. 810.13 Section 810.13 Food... DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810.13 Mandatory recall order. (a) If the person named in a cease distribution and notification order does not request...

  12. 21 CFR 225.135 - Work and storage areas.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Work and storage areas. 225.135 Section 225.135...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Facilities and Equipment § 225.135 Work and storage areas. Work areas and equipment used for the production or storage of medicated feeds...

  13. 21 CFR 26.79 - Territorial application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Territorial application. 26.79 Section 26.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE...

  14. 21 CFR 26.64 - Transitional arrangements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Transitional arrangements. 26.64 Section 26.64 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE...

  15. 21 CFR 26.81 - Final provisions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Final provisions. 26.81 Section 26.81 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT...

  16. 21 CFR 26.78 - Agreements with other countries.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Agreements with other countries. 26.78 Section 26.78 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE...

  17. 21 CFR 26.72 - Sectoral contact points.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Sectoral contact points. 26.72 Section 26.72 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE...

  18. 21 CFR 26.77 - Fees.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Fees. 26.77 Section 26.77 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS:...

  19. 21 CFR 1040.11 - Specific purpose laser products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Specific purpose laser products. 1040.11 Section...) RADIOLOGICAL HEALTH PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS § 1040.11 Specific purpose laser products. (a) Medical laser products. Each medical laser product shall comply with all of the...

  20. 21 CFR 880.6050 - Ice bag.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ice bag. 880.6050 Section 880.6050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES....6050 Ice bag. (a) Identification. An ice bag is a device intended for medical purposes that is in...

  1. 21 CFR 864.8950 - Russell viper venom reagent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Russell viper venom reagent. 864.8950 Section 864.8950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8950 Russell viper...

  2. 21 CFR 864.7720 - Prothrombin consumption test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prothrombin consumption test. 864.7720 Section 864.7720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7720...

  3. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3...

  4. 21 CFR 864.7525 - Heparin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Heparin assay. 864.7525 Section 864.7525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7525 Heparin assay. (a) Identification....

  5. 21 CFR 864.7415 - Abnormal hemoglobin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Abnormal hemoglobin assay. 864.7415 Section 864.7415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7415...

  6. 21 CFR 864.3600 - Microscopes and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microscopes and accessories. 864.3600 Section 864.3600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories §...

  7. 21 CFR 864.5600 - Automated hematocrit instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated hematocrit instrument. 864.5600 Section 864.5600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology...

  8. 21 CFR 864.7275 - Euglobulin lysis time tests.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Euglobulin lysis time tests. 864.7275 Section 864.7275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7275 Euglobulin...

  9. 21 CFR 864.7425 - Carboxyhemoglobin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carboxyhemoglobin assay. 864.7425 Section 864.7425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7425...

  10. 21 CFR 864.5700 - Automated platelet aggregation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated platelet aggregation system. 864.5700 Section 864.5700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology...

  11. 21 CFR 864.6400 - Hematocrit measuring device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hematocrit measuring device. 864.6400 Section 864.6400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6400 Hematocrit...

  12. 21 CFR 864.7875 - Thrombin time test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thrombin time test. 864.7875 Section 864.7875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7875 Thrombin time test....

  13. 21 CFR 864.8100 - Bothrops atrox reagent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bothrops atrox reagent. 864.8100 Section 864.8100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8100 Bothrops atrox reagent....

  14. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Erythrocyte sedimentation rate test. 864.6700 Section 864.6700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6700...

  15. 21 CFR 864.7040 - Adenosine triphosphate release assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Adenosine triphosphate release assay. 864.7040 Section 864.7040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages §...

  16. 21 CFR 864.6100 - Bleeding time device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bleeding time device. 864.6100 Section 864.6100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6100 Bleeding time...

  17. 21 CFR 864.7375 - Glutathione reductase assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Glutathione reductase assay. 864.7375 Section 864.7375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7375...

  18. 21 CFR 864.5620 - Automated hemoglobin system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated hemoglobin system. 864.5620 Section 864.5620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices §...

  19. 21 CFR 864.3250 - Specimen transport and storage container.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Specimen transport and storage container. 864.3250 Section 864.3250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories §...

  20. 21 CFR 864.3260 - OTC test sample collection systems for drugs of abuse testing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false OTC test sample collection systems for drugs of abuse testing. 864.3260 Section 864.3260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES...

  1. 21 CFR 864.3400 - Device for sealing microsections.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Device for sealing microsections. 864.3400 Section 864.3400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories §...

  2. 21 CFR 864.5350 - Microsedimentation centrifuge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microsedimentation centrifuge. 864.5350 Section 864.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology...

  3. 21 CFR 864.6650 - Platelet adhesion test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Platelet adhesion test. 864.6650 Section 864.6650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6650 Platelet...

  4. 21 CFR 864.5680 - Automated heparin analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated heparin analyzer. 864.5680 Section 864.5680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices §...

  5. 21 CFR 864.7340 - Fibrinogen determination system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fibrinogen determination system. 864.7340 Section 864.7340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages §...

  6. 21 CFR 864.5850 - Automated slide spinner.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated slide spinner. 864.5850 Section 864.5850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices §...

  7. 21 CFR 864.3875 - Automated tissue processor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated tissue processor. 864.3875 Section 864.3875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories §...

  8. 21 CFR 864.7675 - Leukocyte peroxidase test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Leukocyte peroxidase test. 864.7675 Section 864.7675 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7675...

  9. 21 CFR 864.7900 - Thromboplastin generation test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thromboplastin generation test. 864.7900 Section 864.7900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages §...

  10. 21 CFR 864.3300 - Cytocentrifuge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cytocentrifuge. 864.3300 Section 864.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories § 864.3300 Cytocentrifuge....

  11. 21 CFR 864.7735 - Prothrombin-proconvertin test and thrombotest.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prothrombin-proconvertin test and thrombotest. 864.7735 Section 864.7735 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages §...

  12. 21 CFR 864.8625 - Hematology quality control mixture.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hematology quality control mixture. 864.8625... (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8625 Hematology quality control mixture. (a) Identification. A hematology quality control mixture is a device used...

  13. 21 CFR 864.1 - Scope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Scope. 864.1 Section 864.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND... hematology and pathology devices intended for human use that are in commercial distribution. (b)...

  14. 21 CFR 864.1860 - Immunohistochemistry reagents and kits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Immunohistochemistry reagents and kits. 864.1860 Section 864.1860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Biological Stains §...

  15. 21 CFR 864.6675 - Platelet aggregometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Platelet aggregometer. 864.6675 Section 864.6675 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6675...

  16. 21 CFR 864.8165 - Calibrator for hemoglobin or hematocrit measurement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Calibrator for hemoglobin or hematocrit measurement. 864.8165 Section 864.8165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents §...

  17. 21 CFR 864.5800 - Automated sedimentation rate device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated sedimentation rate device. 864.5800 Section 864.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology...

  18. 21 CFR 864.7060 - Antithrombin III assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Antithrombin III assay. 864.7060 Section 864.7060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7060 Antithrombin...

  19. 21 CFR 864.7440 - Electrophoretic hemoglobin analysis system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electrophoretic hemoglobin analysis system. 864.7440 Section 864.7440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages §...

  20. 21 CFR 864.7490 - Sulfhemoglobin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Sulfhemoglobin assay. 864.7490 Section 864.7490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7490...

  1. 21 CFR 864.3010 - Tissue processing equipment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tissue processing equipment. 864.3010 Section 864.3010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories §...

  2. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Osmotic fragility test. 864.6600 Section 864.6600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6600 Osmotic...

  3. 21 CFR 864.7695 - Platelet factor 4 radioimmunoassay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Platelet factor 4 radioimmunoassay. 864.7695 Section 864.7695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7695...

  4. 21 CFR 895.101 - Prosthetic hair fibers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthetic hair fibers. 895.101 Section 895.101...) MEDICAL DEVICES BANNED DEVICES Listing of Banned Devices § 895.101 Prosthetic hair fibers. Prosthetic hair fibers are devices intended for implantation into the human scalp to simulate natural hair or...

  5. 21 CFR 886.4280 - Intraocular pressure measuring device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraocular pressure measuring device. 886.4280... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4280 Intraocular pressure measuring device. (a) Identification. An intraocular pressure measuring device is a manual or AC-powered...

  6. 21 CFR 886.4610 - Ocular pressure applicator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ocular pressure applicator. 886.4610 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4610 Ocular pressure applicator. (a) Identification. An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type...

  7. 21 CFR 890.1615 - Miniature pressure transducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Miniature pressure transducer. 890.1615 Section... Miniature pressure transducer. (a) Identification. A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical...

  8. 21 CFR 890.1600 - Intermittent pressure measurement system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intermittent pressure measurement system. 890.1600... Intermittent pressure measurement system. (a) Identification. An intermittent pressure measurement system is an evaluative device intended for medical purposes, such as to measure the actual pressure between the...

  9. 21 CFR 868.2600 - Airway pressure monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Airway pressure monitor. 868.2600 Section 868.2600...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2600 Airway pressure monitor. (a) Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper...

  10. 21 CFR 868.1780 - Inspiratory airway pressure meter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Inspiratory airway pressure meter. 868.1780... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1780 Inspiratory airway pressure meter. (a) Identification. An inspiratory airway pressure meter is a device used to measure the...

  11. 21 CFR 870.1110 - Blood pressure computer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure computer. 870.1110 Section 870.1110...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1110 Blood pressure computer. (a) Identification. A blood pressure computer is a device that accepts the electrical signal...

  12. 21 CFR 868.2610 - Gas pressure gauge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas pressure gauge. 868.2610 Section 868.2610 Food... DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2610 Gas pressure gauge. (a) Identification. A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intended for medical purposes that is...

  13. 21 CFR 868.5860 - Pressure tubing and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pressure tubing and accessories. 868.5860 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5860 Pressure tubing and accessories. (a) Identification. Pressure tubing and accessories are flexible or rigid devices intended...

  14. 21 CFR 868.2875 - Differential pressure transducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Differential pressure transducer. 868.2875 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2875 Differential pressure transducer. (a) Identification. A differential pressure transducer is a two-chambered device intended...

  15. 21 CFR 870.1100 - Blood pressure alarm.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood...

  16. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  17. 21 CFR 880.6450 - Skin pressure protectors.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Skin pressure protectors. 880.6450 Section 880... Devices § 880.6450 Skin pressure protectors. (a) Identification. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to...

  18. 21 CFR 868.1750 - Pressure plethysmograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pressure plethysmograph. 868.1750 Section 868.1750...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1750 Pressure plethysmograph. (a) Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and...

  19. 21 CFR 872.3080 - Mercury and alloy dispenser.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mercury and alloy dispenser. 872.3080 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3080 Mercury and alloy dispenser. (a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure...

  20. 21 CFR 872.3070 - Dental amalgam, mercury, and amalgam alloy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental amalgam, mercury, and amalgam alloy. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3070 Dental amalgam, mercury... elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam...

  1. 21 CFR 868.5160 - Gas machine for anesthesia or analgesia.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas machine for anesthesia or analgesia. 868.5160... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5160 Gas machine for anesthesia or analgesia. (a) Gas machine for anesthesia—(1) Identification. A gas machine for anesthesia is...

  2. 21 CFR 880.5140 - Pediatric hospital bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pediatric hospital bed. 880.5140 Section 880.5140... Devices § 880.5140 Pediatric hospital bed. (a) Identification. A pediatric hospital bed is a device intended for medical purposes that consists of a bed or crib designed for the use of a pediatric...

  3. 25 CFR 900.195 - Does FTCA coverage extend to the contractor's health care practitioners providing services to...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 2 2012-04-01 2012-04-01 false Does FTCA coverage extend to the contractor's health care... AFFAIRS, DEPARTMENT OF THE INTERIOR, AND INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES... General Provisions Medical-Related Claims § 900.195 Does FTCA coverage extend to the contractor's...

  4. 20 CFR 10.322 - Who pays for second opinion and referee examinations?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Who pays for second opinion and referee examinations? 10.322 Section 10.322 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF... second opinion and referee examinations? OWCP will pay second opinion and referee medical...

  5. 21 CFR 801.415 - Maximum acceptable level of ozone.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Conference of Governmental Industrial Hygienists. (e) The method and apparatus specified in 40 CFR part 50... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Maximum acceptable level of ozone. 801.415 Section... level of ozone. (a) Ozone is a toxic gas with no known useful medical application in...

  6. 21 CFR 870.2750 - Impedance phlebograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Impedance phlebograph. 870.2750 Section 870.2750...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2750 Impedance phlebograph. (a) Identification. An impedance phlebograph is a device used to provide a visual display of...

  7. 21 CFR 870.2770 - Impedance plethysmograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Impedance plethysmograph. 870.2770 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2770 Impedance plethysmograph. (a) Identification. An impedance plethysmograph is a device used to estimate peripheral...

  8. 21 CFR 226.102 - Master-formula and batch-production records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Master-formula and batch-production records. 226... Records and Reports § 226.102 Master-formula and batch-production records. (a) For each Type A medicated... batch size, or of appropriate size in the case of continuous systems to be produced from the...

  9. 21 CFR 886.1460 - Stereopsis measuring instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Stereopsis measuring instrument. 886.1460 Section 886.1460 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1460 Stereopsis measuring instrument. (a) Identification. A stereopsis...

  10. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted...

  11. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic bar reader. 886.5800 Section...

  12. 21 CFR 876.5860 - High permeability hemodialysis system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false High permeability hemodialysis system. 876.5860 Section 876.5860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876.5860 High...

  13. 21 CFR 868.5995 - Tee drain (water trap).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tee drain (water trap). 868.5995 Section 868.5995...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5995 Tee drain (water trap). (a) Identification. A tee drain (water trap) is a device intended to trap and drain water that collects in...

  14. 21 CFR 872.6710 - Boiling water sterilizer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Boiling water sterilizer. 872.6710 Section 872...) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6710 Boiling water sterilizer. (a) Identification. A boiling water sterilizer is an AC-powered device that consists of a container for boiling...

  15. 21 CFR 880.5560 - Temperature regulated water mattress.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Temperature regulated water mattress. 880.5560... Therapeutic Devices § 880.5560 Temperature regulated water mattress. (a) Identification. A temperature regulated water mattress is a device intended for medical purposes that consists of a mattress of...

  16. 21 CFR 868.1975 - Water vapor analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Water vapor analyzer. 868.1975 Section 868.1975...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1975 Water vapor analyzer. (a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in...

  17. 20 CFR 220.176 - When disability continues or ends.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false When disability continues or ends. 220.176... ACT DETERMINING DISABILITY Continuing or Stopping Disability Due to Substantial Gainful Activity or Medical Improvement § 220.176 When disability continues or ends. There is a statutory requirement that,...

  18. 21 CFR 886.5925 - Soft (hydrophilic) contact lens.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Soft (hydrophilic) contact lens. 886.5925 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5925 Soft (hydrophilic) contact lens. (a) Identification. A soft (hydrophilic) contact lens is a device intended to be worn...

  19. 21 CFR 882.5960 - Skull tongs for traction.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Skull tongs for traction. 882.5960 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5960 Skull tongs for traction. (a) Identification. Skull tongs for traction is an instrument used to immobilize a patient with...

  20. 21 CFR 882.5175 - Carotid artery clamp.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carotid artery clamp. 882.5175 Section 882.5175...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5175 Carotid artery clamp. (a) Identification. A carotid artery clamp is a device that is surgically placed around a patient's carotid...

  1. 21 CFR 870.4875 - Intraluminal artery stripper.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraluminal artery stripper. 870.4875 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4875 Intraluminal artery stripper. (a) Identification. An intraluminal artery stripper is a device used to perform an...

  2. 21 CFR 880.2720 - Patient scale.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... transducers, electronic signal amplification, conditioning and display equipment. (b) Classification. Class I... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Patient scale. 880.2720 Section 880.2720 Food and... Patient scale. (a) Identification. A patient scale is a device intended for medical purposes that is...

  3. 21 CFR 864.9750 - Heat-sealing device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Heat-sealing device. 864.9750 Section 864.9750... and Blood Products § 864.9750 Heat-sealing device. (a) Identification. A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or...

  4. 21 CFR 880.6870 - Dry-heat sterilizer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dry-heat sterilizer. 880.6870 Section 880.6870... Devices § 880.6870 Dry-heat sterilizer. (a) Identification. A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat....

  5. 21 CFR 880.6200 - Ring cutter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ring cutter. 880.6200 Section 880.6200 Food and....6200 Ring cutter. (a) Identification. A ring cutter is a device intended for medical purposes that is used to cut a ring on a patient's finger so that the ring can be removed. The device incorporates...

  6. 21 CFR 866.1700 - Culture medium for antimicrobial susceptibility tests.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Culture medium for antimicrobial susceptibility....1700 Culture medium for antimicrobial susceptibility tests. (a) Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium...

  7. 21 CFR 882.1275 - Electroconductive media.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electroconductive media. 882.1275 Section 882.1275...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1275 Electroconductive media. (a) Identification. Electroconductive media are the conductive creams or gels used with...

  8. 21 CFR 866.2440 - Automated medium dispensing and stacking device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated medium dispensing and stacking device... Automated medium dispensing and stacking device. (a) Identification. An automated medium dispensing and stacking device is a device intended for medical purposes to dispense a microbiological culture medium...

  9. 21 CFR 866.2480 - Quality control kit for culture media.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Quality control kit for culture media. 866.2480... control kit for culture media. (a) Identification. A quality control kit for culture media is a device...-dried, viable microorganism, intended for medical purposes to determine if a given culture medium...

  10. 21 CFR 886.5870 - Low-vision telescope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Low-vision telescope. 886.5870 Section 886.5870...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5870 Low-vision telescope. (a) Identification. A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended...

  11. 21 CFR 886.5900 - Electronic vision aid.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electronic vision aid. 886.5900 Section 886.5900...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5900 Electronic vision aid. (a) Identification. An electronic vision aid is an AC-powered or battery-powered device that consists of...

  12. 21 CFR 886.1170 - Color vision tester.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Color vision tester. 886.1170 Section 886.1170...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1170 Color vision tester. (a) Identification. A color vision tester is a device that consists of various colored materials, such as colored...

  13. 21 CFR 886.1160 - Color vision plate illuminator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Color vision plate illuminator. 886.1160 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1160 Color vision plate illuminator. (a) Identification. A color vision plate illuminator is an AC-powered device that is a lamp...

  14. 21 CFR 886.5910 - Image intensification vision aid.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Image intensification vision aid. 886.5910 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5910 Image intensification vision aid. (a) Identification. An image intensification vision aid is a battery-powered device intended...

  15. 21 CFR 886.5540 - Low-vision magnifier.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Low-vision magnifier. 886.5540 Section 886.5540...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5540 Low-vision magnifier. (a) Identification. A low-vision magnifier is a device that consists of a magnifying lens intended for use by a...

  16. 21 CFR 892.1390 - Radionuclide rebreathing system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radionuclide rebreathing system. 892.1390 Section 892.1390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1390 Radionuclide rebreathing system. (a) Identification. A radionuclide...

  17. 21 CFR 872.3770 - Temporary crown and bridge resin.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Temporary crown and bridge resin. 872.3770 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3770 Temporary crown and bridge resin. (a) Identification. A temporary crown and bridge resin is a device composed of a material, such...

  18. 21 CFR 868.1690 - Nitrogen gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitrogen gas analyzer. 868.1690 Section 868.1690...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1690 Nitrogen gas analyzer. (a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen...

  19. 21 CFR 868.2385 - Nitrogen dioxide analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitrogen dioxide analyzer. 868.2385 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2385 Nitrogen dioxide analyzer. (a) Identification. The nitrogen dioxide analyzer is a device intended to measure the concentration of...

  20. 21 CFR 882.1525 - Tuning fork.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tuning fork. 882.1525 Section 882.1525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1525 Tuning fork. (a) Identification. A tuning...

  1. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  2. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  3. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  4. 21 CFR 864.9125 - Vacuum-assisted blood collection system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vacuum-assisted blood collection system. 864.9125... Blood and Blood Products § 864.9125 Vacuum-assisted blood collection system. (a) Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum...

  5. 20 CFR 638.510 - Health care and services.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Health care and services. 638.510 Section 638... UNDER TITLE IV-B OF THE JOB TRAINING PARTNERSHIP ACT Center Operations § 638.510 Health care and services. The center operator shall provide a health program, including basic medical, dental, and...

  6. 21 CFR 73.3110a - Chromium-cobalt-aluminum oxide.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Chromium-cobalt-aluminum oxide. 73.3110a Section... LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3110a Chromium-cobalt-aluminum oxide. (a) Identity. The color additive chromium-cobalt-aluminum oxide (Pigment Blue 36) (CAS Reg....

  7. 21 CFR 868.5935 - External negative pressure ventilator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External negative pressure ventilator. 868.5935... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5935 External negative pressure ventilator. (a) Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is...

  8. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended...

  9. 21 CFR 886.1510 - Eye movement monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Eye movement monitor. 886.1510 Section 886.1510...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1510 Eye movement monitor. (a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and...

  10. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3320 Eye sphere implant. (a) Identification. An...

  11. 21 CFR 886.1670 - Ophthalmic isotope uptake probe.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to...

  12. 21 CFR 862.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General...

  13. 21 CFR 862.2 - Regulation of calibrators.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Regulation of calibrators. 862.2 Section 862.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.2...

  14. 21 CFR 25.34 - Devices and electronic products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an...

  15. 21 CFR 882.5975 - Human dura mater.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Human dura mater. 882.5975 Section 882.5975 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5975 Human dura mater....

  16. 21 CFR 225.202 - Formula, production, and distribution records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Formula, production, and distribution records. 225.202 Section 225.202 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records §...

  17. 21 CFR 225.180 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Labeling. 225.180 Section 225.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Labeling § 225.180 Labeling. Labels shall...

  18. 21 CFR 872.3820 - Root canal filling resin.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Root canal filling resin. 872.3820 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3820 Root canal filling resin. (a) Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate,...

  19. 21 CFR 864.4400 - Enzyme preparations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Enzyme preparations. 864.4400 Section 864.4400...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Specimen Preparation Reagents § 864.4400 Enzyme preparations. (a) Identification. Enzyme preparations are products that are used in the...

  20. 21 CFR 882.4325 - Cranial drill handpiece (brace).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cranial drill handpiece (brace). 882.4325 Section... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4325 Cranial drill handpiece (brace). (a) Identification. A cranial drill handpiece (brace) is a hand holder, which is...

  1. 21 CFR 872.4130 - Intraoral dental drill.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraoral dental drill. 872.4130 Section 872.4130...) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4130 Intraoral dental drill. (a) Identification. An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes...

  2. 21 CFR 882.4360 - Electric cranial drill motor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electric cranial drill motor. 882.4360 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4360 Electric cranial drill motor. (a) Identification. An electric cranial drill motor is an electrically operated power source...

  3. 21 CFR 73.3119 - 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone. 73.3119 Section 73.3119 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3119...

  4. 21 CFR 73.3106 - 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false 1,4-Bis anthraquinone copolymers. 73.3106 Section 73.3106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3106 1,4-Bis...

  5. 21 CFR 73.3122 - 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false 4- -2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one. 73.3122 Section 73.3122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3122 4-...

  6. 21 CFR 73.3120 - 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false 16,17-Dimethoxydinaphtho perylene-5,10-dione. 73.3120 Section 73.3120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3120...

  7. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vaginal stent. 884.3900 Section 884.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or...

  8. 21 CFR 73.3125 - Iron oxides.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Iron oxides. 73.3125 Section 73.3125 Food and... ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3125 Iron oxides. (a) Identity and specifications. The color additive iron oxides (CAS Reg. No. 1332-37-2), Color Index No. 77491, shall conform...

  9. 21 CFR 872.6200 - Base plate shellac.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Base plate shellac. 872.6200 Section 872.6200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6200 Base plate shellac. (a) Identification. Base...

  10. 21 CFR 872.6650 - Massaging pick or tip for oral hygiene.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Massaging pick or tip for oral hygiene. 872.6650... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6650 Massaging pick or tip for oral hygiene. (a) Identification. A massaging pick or tip for oral hygiene is a rigid, pointed device...

  11. 21 CFR 820.20 - Management responsibility.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Management responsibility. 820.20 Section 820.20...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Quality System Requirements § 820.20 Management responsibility. (a) Quality policy. Management with executive responsibility shall establish its policy...

  12. 20 CFR 220.182 - Before a disability annuity is stopped.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Before a disability annuity is stopped. 220... RETIREMENT ACT DETERMINING DISABILITY Continuing or Stopping Disability Due to Substantial Gainful Activity or Medical Improvement § 220.182 Before a disability annuity is stopped. Before the Board stops...

  13. 20 CFR 718.105 - Arterial blood-gas studies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Arterial blood-gas studies. 718.105 Section... blood-gas studies. (a) Blood-gas studies are performed to detect an impairment in the process of... either at rest or during exercise. No blood-gas study shall be performed if medically contraindicated....

  14. 21 CFR 864.9185 - Blood grouping view box.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood grouping view box. 864.9185 Section 864.9185...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9185 Blood grouping view box. (a) Identification. A blood grouping view...

  15. 21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood...

  16. 21 CFR 864.9050 - Blood bank supplies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood bank supplies. 864.9050 Section 864.9050...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9050 Blood bank supplies. (a) Identification. Blood bank supplies are...

  17. 21 CFR 862.1675 - Blood specimen collection device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood specimen collection device. 862.1675 Section... Systems § 862.1675 Blood specimen collection device. (a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to...

  18. 21 CFR 876.5540 - Blood access device and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood access device and accessories. 876.5540... (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876.5540 Blood access device and accessories. (a) Identification. A blood access device and accessories is a device intended...

  19. 21 CFR 880.6185 - Cast cover.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cast cover. 880.6185 Section 880.6185 Food and....6185 Cast cover. (a) Identification. A cast cover is a device intended for medical purposes that is made of waterproof material and placed over a cast to protect it from getting wet during a shower or...

  20. 21 CFR 888.5960 - Cast removal instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cast removal instrument. 888.5960 Section 888.5960...) MEDICAL DEVICES ORTHOPEDIC DEVICES Surgical Devices § 888.5960 Cast removal instrument. (a) Identification. A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from...

  1. 21 CFR 888.5940 - Cast component.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cast component. 888.5940 Section 888.5940 Food and... ORTHOPEDIC DEVICES Surgical Devices § 888.5940 Cast component. (a) Identification. A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device...

  2. 21 CFR 888.5980 - Manual cast application and removal instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual cast application and removal instrument... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Surgical Devices § 888.5980 Manual cast application and removal instrument. (a) Identification. A manual cast application and removal instrument is...

  3. 21 CFR 864.2240 - Cell and tissue culture supplies and equipment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cell and tissue culture supplies and equipment... SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Cell And Tissue Culture Products § 864.2240 Cell and tissue culture supplies and equipment. (a) Identification. Cell and tissue...

  4. 21 CFR 864.7100 - Red blood cell enzyme assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Red blood cell enzyme assay. 864.7100 Section 864...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7100 Red blood cell enzyme assay. (a) Identification. Red blood cell enzyme assay is a device used to measure the activity...

  5. 21 CFR 864.8540 - Red cell lysing reagent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Red cell lysing reagent. 864.8540 Section 864.8540...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8540 Red cell lysing reagent. (a) Identification. A red cell lysing reagent is a device used to lyse (destroy) red blood cells...

  6. 21 CFR 864.2220 - Synthetic cell and tissue culture media and components.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Synthetic cell and tissue culture media and... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Cell And Tissue Culture Products § 864.2220 Synthetic cell and tissue culture media and components. (a) Identification....

  7. 21 CFR 864.8150 - Calibrator for cell indices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Calibrator for cell indices. 864.8150 Section 864...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8150 Calibrator for cell indices. (a) Identification. A calibrator for cell indices is a device that approximates whole blood...

  8. 21 CFR 864.2280 - Cultured animal and human cells.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cultured animal and human cells. 864.2280 Section... (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Cell And Tissue Culture Products § 864.2280 Cultured animal and human cells. (a) Identification. Cultured animal and human cells are in...

  9. 21 CFR 864.2260 - Chromosome culture kit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chromosome culture kit. 864.2260 Section 864.2260...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Cell And Tissue Culture Products § 864.2260 Chromosome culture kit. (a) Identification. A chromosome culture kit is a device containing the necessary...

  10. 21 CFR 872.6870 - Disposable fluoride tray.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Disposable fluoride tray. 872.6870 Section 872...) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6870 Disposable fluoride tray. (a) Identification. A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically...

  11. 21 CFR 872.4535 - Dental diamond instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental diamond instrument. 872.4535 Section 872...) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4535 Dental diamond instrument. (a) Identification. A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during...

  12. 21 CFR 73.3107 - Carbazole violet.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Carbazole violet. 73.3107 Section 73.3107 Food and... ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3107 Carbazole violet. (a) Identity. The color additive is carbazole violet (Pigment Violet 23) (CAS Reg. No. 6358-30-1, Colour Index No. 51319). (b)...

  13. 20 CFR 416.1015 - Making disability determinations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Making disability determinations. 416.1015... Determination Function § 416.1015 Making disability determinations. (a) When making a disability determination... evaluated (i.e., no medical evidence exists or we are unable, despite making every reasonable effort,...

  14. 20 CFR 404.1615 - Making disability determinations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Making disability determinations. 404.1615... Determination Function § 404.1615 Making disability determinations. (a) When making a disability determination... evaluated (i.e., no medical evidence exists or we are unable, despite making every reasonable effort,...

  15. 21 CFR 886.1880 - Fusion and stereoscopic target.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fusion and stereoscopic target. 886.1880 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1880 Fusion and stereoscopic target. (a) Identification. A fusion and stereoscopic target is a device intended for use as a viewing...

  16. 21 CFR 808.73 - Minnesota.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Minnesota. 808.73 Section 808.73 Food and Drugs... and Local Exemptions § 808.73 Minnesota. The following Minnesota medical device requirements are... from preemption under section 521(b) of the act: Minnesota Statutes, sections 145.43 and 145.44....

  17. 20 CFR 10.316 - After selecting a treating physician, may an employee choose to be treated by another physician...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false After selecting a treating physician, may an employee choose to be treated by another physician instead? 10.316 Section 10.316 Employees' Benefits... Benefits Medical Treatment and Related Issues § 10.316 After selecting a treating physician, may...

  18. 21 CFR 892.1560 - Ultrasonic pulsed echo imaging system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1560 Ultrasonic pulsed echo imaging system. (a) Identification. An ultrasonic pulsed echo imaging system is a device intended to project a... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ultrasonic pulsed echo imaging system....

  19. 21 CFR 820.70 - Production and process controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Production and process controls. 820.70 Section 820.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Production and Process Controls § 820.70 Production and process controls. (a) General. Each...

  20. 21 CFR 886.4115 - Thermal cautery unit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thermal cautery unit. 886.4115 Section 886.4115...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4115 Thermal cautery unit. (a) Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery...

  1. 21 CFR 880.6890 - General purpose disinfectants.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false General purpose disinfectants. 880.6890 Section... Miscellaneous Devices § 880.6890 General purpose disinfectants. (a) Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A...

  2. 20 CFR 220.114 - Evaluation of symptoms, including pain.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Evaluation of symptoms, including pain. 220... RETIREMENT ACT DETERMINING DISABILITY Medical Considerations § 220.114 Evaluation of symptoms, including pain...'s symptoms, including pain, and the extent to which the claimant's symptoms can reasonably...

  3. 21 CFR 866.3850 - Trichinella spiralis serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Trichinella spiralis serological reagents. 866.3850 Section 866.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  4. 21 CFR 866.3680 - Sporothrix schenckii serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Sporothrix schenckii serological reagents. 866.3680 Section 866.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  5. 21 CFR 866.3660 - Shigella spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shigella spp. serological reagents. 866.3660 Section 866.3660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3660 Shigella...

  6. 21 CFR 866.3630 - Serratia spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Serratia spp. serological reagents. 866.3630 Section 866.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3630 Serratia...

  7. 21 CFR 866.3520 - Rubeola (measles) virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rubeola (measles) virus serological reagents. 866.3520 Section 866.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  8. 21 CFR 890.1850 - Diagnostic muscle stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic muscle stimulator. 890.1850 Section 890... muscle stimulator. (a) Identification. A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to...

  9. 21 CFR 890.5850 - Powered muscle stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered muscle stimulator. 890.5850 Section 890...) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5850 Powered muscle stimulator. (a) Identification. A powered muscle stimulator is an electrically powered device intended...

  10. 21 CFR 890.5860 - Ultrasound and muscle stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ultrasound and muscle stimulator. 890.5860 Section... Ultrasound and muscle stimulator. (a) Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions—(1) Identification. An ultrasound and muscle stimulator for use...

  11. 21 CFR 886.5100 - Ophthalmic beta radiation source.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply...

  12. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiation therapy simulation system. 892.5840... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy simulation system. (a) Identification. A radiation therapy simulation system is a fluoroscopic or radiographic...

  13. 21 CFR 892.5750 - Radionuclide radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radionuclide radiation therapy system. 892.5750... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5750 Radionuclide radiation therapy system. (a) Identification. A radionuclide radiation therapy system is a device intended to permit...

  14. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  15. 21 CFR 892.5710 - Radiation therapy beam-shaping block.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiation therapy beam-shaping block. 892.5710... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5710 Radiation therapy beam-shaping block. (a) Identification. A radiation therapy beam-shaping block is a device made of a...

  16. 21 CFR 868.1730 - Oxygen uptake computer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oxygen uptake computer. 868.1730 Section 868.1730...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1730 Oxygen uptake computer. (a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by...

  17. 21 CFR 876.4500 - Mechanical lithotriptor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical lithotriptor. 876.4500 Section 876.4500...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Surgical Devices § 876.4500 Mechanical lithotriptor. (a) Identification. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary...

  18. 21 CFR 872.3530 - Mechanical denture cleaner.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical denture cleaner. 872.3530 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3530 Mechanical denture cleaner. (a) Identification. A mechanical denture cleaner is a device, usually AC-powered, that consists of a container...

  19. 21 CFR 868.5550 - Anesthetic gas mask.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Anesthetic gas mask. 868.5550 Section 868.5550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5550 Anesthetic gas mask....

  20. 21 CFR 868.2025 - Ultrasonic air embolism monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ultrasonic air embolism monitor. 868.2025 Section 868.2025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2025 Ultrasonic air...

  1. 21 CFR 868.1900 - Diagnostic pulmonary-function interpretation calculator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic pulmonary-function interpretation calculator. 868.1900 Section 868.1900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices §...

  2. 21 CFR 868.1760 - Volume plethysmograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Volume plethysmograph. 868.1760 Section 868.1760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1760 Volume plethysmograph....

  3. 21 CFR 868.1965 - Switching valve (ploss).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Switching valve (ploss). 868.1965 Section 868.1965 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1965 Switching valve (ploss)....

  4. 21 CFR 868.5600 - Venturi mask.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Venturi mask. 868.5600 Section 868.5600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5600 Venturi mask. (a) Identification. A venturi mask is...

  5. 21 CFR 868.5340 - Nasal oxygen cannula.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nasal oxygen cannula. 868.5340 Section 868.5340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5340 Nasal oxygen cannula....

  6. 21 CFR 868.1640 - Helium gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Helium gas analyzer. 868.1640 Section 868.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1640 Helium gas analyzer....

  7. 21 CFR 868.5140 - Anesthesia conduction kit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Anesthesia conduction kit. 868.5140 Section 868.5140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5140 Anesthesia conduction kit....

  8. 21 CFR 868.1930 - Stethoscope head.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Stethoscope head. 868.1930 Section 868.1930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1930 Stethoscope head. (a) Identification....

  9. 21 CFR 868.5580 - Oxygen mask.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oxygen mask. 868.5580 Section 868.5580 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5580 Oxygen mask. (a) Identification. An oxygen mask is a...

  10. 21 CFR 868.5120 - Anesthesia conduction catheter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Anesthesia conduction catheter. 868.5120 Section 868.5120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5120 Anesthesia...

  11. 21 CFR 868.2377 - Apnea monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Apnea monitor. 868.2377 Section 868.2377 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2377 Apnea monitor. (a) Identification. An apnea monitor is...

  12. 21 CFR 868.5365 - Posture chair for cardiac or pulmonary treatment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Posture chair for cardiac or pulmonary treatment. 868.5365 Section 868.5365 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5365 Posture...

  13. 21 CFR 868.1075 - Argon gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Argon gas analyzer. 868.1075 Section 868.1075 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1075 Argon gas analyzer. (a) Identification....

  14. 21 CFR 868.1030 - Manual algesimeter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual algesimeter. 868.1030 Section 868.1030 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1030 Manual algesimeter. (a) Identification....

  15. 21 CFR 868.1040 - Powered algesimeter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered algesimeter. 868.1040 Section 868.1040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1040 Powered algesimeter....

  16. 21 CFR 868.5110 - Oropharyngeal airway.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oropharyngeal airway. 868.5110 Section 868.5110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5110 Oropharyngeal airway....

  17. 21 CFR 868.5250 - Breathing circuit circulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing circuit circulator. 868.5250 Section 868.5250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5250 Breathing circuit circulator....

  18. 21 CFR 868.1720 - Oxygen gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oxygen gas analyzer. 868.1720 Section 868.1720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1720 Oxygen gas analyzer....

  19. 21 CFR 868.1120 - Indwelling blood oxyhemoglobin concentration analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Indwelling blood oxyhemoglobin concentration analyzer. 868.1120 Section 868.1120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices §...

  20. 21 CFR 868.5150 - Anesthesia conduction needle.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Anesthesia conduction needle. 868.5150 Section 868.5150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5150 Anesthesia conduction needle....

  1. 21 CFR 868.2550 - Pneumotachometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pneumotachometer. 868.2550 Section 868.2550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2550 Pneumotachometer. (a) Identification....

  2. 21 CFR 868.5100 - Nasopharyngeal airway.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nasopharyngeal airway. 868.5100 Section 868.5100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5100 Nasopharyngeal airway....

  3. 21 CFR 868.5460 - Therapeutic humidifier for home use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Therapeutic humidifier for home use. 868.5460 Section 868.5460 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5460 Therapeutic humidifier...

  4. 21 CFR 868.5280 - Breathing tube support.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing tube support. 868.5280 Section 868.5280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5280 Breathing tube support....

  5. 21 CFR 868.5220 - Blow bottle.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blow bottle. 868.5220 Section 868.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5220 Blow bottle. (a) Identification. A blow bottle is a...

  6. 21 CFR 868.5400 - Electroanesthesia apparatus.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electroanesthesia apparatus. 868.5400 Section 868.5400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5400 Electroanesthesia apparatus....

  7. 21 CFR 868.5320 - Reservoir bag.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Reservoir bag. 868.5320 Section 868.5320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5320 Reservoir bag. (a) Identification. A reservoir bag is...

  8. 21 CFR 868.1920 - Esophageal stethoscope with electrical conductors.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Esophageal stethoscope with electrical conductors. 868.1920 Section 868.1920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1920...

  9. 21 CFR 868.2380 - Nitric oxide analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitric oxide analyzer. 868.2380 Section 868.2380 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2380 Nitric oxide analyzer....

  10. 21 CFR 868.1100 - Arterial blood sampling kit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Arterial blood sampling kit. 868.1100 Section 868.1100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1100 Arterial blood sampling kit....

  11. 21 CFR 868.1840 - Diagnostic spirometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic spirometer. 868.1840 Section 868.1840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1840 Diagnostic spirometer....

  12. 21 CFR 868.5540 - Rigid laryngoscope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rigid laryngoscope. 868.5540 Section 868.5540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5540 Rigid laryngoscope. (a) Identification....

  13. 21 CFR 868.1575 - Gas collection vessel.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas collection vessel. 868.1575 Section 868.1575 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1575 Gas collection vessel....

  14. 21 CFR 868.1880 - Pulmonary-function data calculator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pulmonary-function data calculator. 868.1880 Section 868.1880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1880 Pulmonary-function...

  15. 21 CFR 868.1200 - Indwelling blood oxygen partial pressure (PO2) analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Indwelling blood oxygen partial pressure (PO2) analyzer. 868.1200 Section 868.1200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices §...

  16. 21 CFR 868.5240 - Anesthesia breathing circuit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Anesthesia breathing circuit. 868.5240 Section 868.5240 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5240 Anesthesia breathing circuit....

  17. 21 CFR 868.5350 - Nasal oxygen catheter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nasal oxygen catheter. 868.5350 Section 868.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5350 Nasal oxygen catheter....

  18. 21 CFR 868.5570 - Nonrebreathing mask.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonrebreathing mask. 868.5570 Section 868.5570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5570 Nonrebreathing mask....

  19. 21 CFR 868.1500 - Enflurane gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Enflurane gas analyzer. 868.1500 Section 868.1500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1500 Enflurane gas analyzer....

  20. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 868.9 Section 868.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY...

  1. 21 CFR 868.2885 - Gas flow transducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas flow transducer. 868.2885 Section 868.2885 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2885 Gas flow transducer....

  2. 21 CFR 868.5375 - Heat and moisture condenser (artificial nose).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Heat and moisture condenser (artificial nose). 868.5375 Section 868.5375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5375 Heat...

  3. 21 CFR 868.1670 - Neon gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Neon gas analyzer. 868.1670 Section 868.1670 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1670 Neon gas analyzer. (a) Identification. A...

  4. 21 CFR 868.5260 - Breathing circuit bacterial filter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing circuit bacterial filter. 868.5260 Section 868.5260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5260 Breathing circuit...

  5. 21 CFR 868.5115 - Device to relieve acute upper airway obstruction.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Device to relieve acute upper airway obstruction. 868.5115 Section 868.5115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5115 Device...

  6. 21 CFR 868.5330 - Breathing gas mixer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing gas mixer. 868.5330 Section 868.5330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5330 Breathing gas mixer....

  7. 21 CFR 868.5090 - Emergency airway needle.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Emergency airway needle. 868.5090 Section 868.5090 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5090 Emergency airway needle....

  8. 21 CFR 868.2350 - Gas calibration flowmeter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas calibration flowmeter. 868.2350 Section 868.2350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2350 Gas calibration flowmeter....

  9. 21 CFR 868.5590 - Scavenging mask.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Scavenging mask. 868.5590 Section 868.5590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5590 Scavenging mask. (a) Identification....

  10. 21 CFR 868.1910 - Esophageal stethoscope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Esophageal stethoscope. 868.1910 Section 868.1910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1910 Esophageal stethoscope....

  11. 21 CFR 868.2340 - Compensated thorpe tube flowmeter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Compensated thorpe tube flowmeter. 868.2340 Section 868.2340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2340 Compensated thorpe...

  12. 21 CFR 868.5180 - Rocking bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rocking bed. 868.5180 Section 868.5180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5180 Rocking bed. (a) Identification. A rocking bed is a...

  13. 21 CFR 868.1850 - Monitoring spirometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Monitoring spirometer. 868.1850 Section 868.1850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1850 Monitoring spirometer....

  14. 21 CFR 868.5130 - Anesthesia conduction filter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Anesthesia conduction filter. 868.5130 Section 868.5130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5130 Anesthesia conduction filter....

  15. 21 CFR 868.5430 - Gas-scavenging apparatus.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas-scavenging apparatus. 868.5430 Section 868.5430 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5430 Gas-scavenging apparatus....

  16. 21 CFR 868.5165 - Nitric oxide administration apparatus.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitric oxide administration apparatus. 868.5165 Section 868.5165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5165 Nitric oxide...

  17. 21 CFR 868.1430 - Carbon monoxide gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carbon monoxide gas analyzer. 868.1430 Section 868.1430 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1430 Carbon monoxide gas analyzer....

  18. 21 CFR 868.2500 - Cutaneous oxygen (PcO2) monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cutaneous oxygen (PcO2) monitor. 868.2500 Section 868.2500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2500 Cutaneous oxygen...

  19. 21 CFR 868.1800 - Rhinoanemometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rhinoanemometer. 868.1800 Section 868.1800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1800 Rhinoanemometer. (a) Identification....

  20. 21 CFR 868.5170 - Laryngotracheal topical anesthesia applicator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Laryngotracheal topical anesthesia applicator. 868.5170 Section 868.5170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5170...

  1. 21 CFR 868.1860 - Peak-flow meter for spirometry.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Peak-flow meter for spirometry. 868.1860 Section 868.1860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1860 Peak-flow meter...

  2. 21 CFR 868.5450 - Respiratory gas humidifier.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Respiratory gas humidifier. 868.5450 Section 868.5450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5450 Respiratory gas humidifier....

  3. 21 CFR 868.5470 - Hyperbaric chamber.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hyperbaric chamber. 868.5470 Section 868.5470 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5470 Hyperbaric chamber. (a) Identification....

  4. 21 CFR 868.2300 - Bourdon gauge flowmeter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bourdon gauge flowmeter. 868.2300 Section 868.2300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2300 Bourdon gauge flowmeter....

  5. 21 CFR 868.1870 - Gas volume calibrator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas volume calibrator. 868.1870 Section 868.1870 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1870 Gas volume calibrator....

  6. 21 CFR 868.1700 - Nitrous oxide gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitrous oxide gas analyzer. 868.1700 Section 868.1700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1700 Nitrous oxide gas analyzer....

  7. 21 CFR 868.5560 - Gas mask head strap.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas mask head strap. 868.5560 Section 868.5560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5560 Gas mask head strap....

  8. 21 CFR 868.2375 - Breathing frequency monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing frequency monitor. 868.2375 Section 868.2375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2375 Breathing frequency monitor....

  9. 21 CFR 868.2320 - Uncompensated thorpe tube flowmeter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Uncompensated thorpe tube flowmeter. 868.2320 Section 868.2320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2320 Uncompensated thorpe...

  10. 21 CFR 868.5420 - Ether hook.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ether hook. 868.5420 Section 868.5420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5420 Ether hook. (a) Identification. An ether hook is a...

  11. 21 CFR 868.5270 - Breathing system heater.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing system heater. 868.5270 Section 868.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5270 Breathing system heater....

  12. 21 CFR 868.5530 - Flexible laryngoscope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Flexible laryngoscope. 868.5530 Section 868.5530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5530 Flexible laryngoscope....

  13. 21 CFR 868.1620 - Halothane gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Halothane gas analyzer. 868.1620 Section 868.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1620 Halothane gas analyzer....

  14. 21 CFR 868.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 868.3 Section 868.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.3 Effective dates...

  15. 21 CFR 868.1890 - Predictive pulmonary-function value calculator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Predictive pulmonary-function value calculator. 868.1890 Section 868.1890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1890...

  16. 21 CFR 820.184 - Device history record.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures...

  17. 21 CFR 870.3945 - Prosthetic heart valve sizer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthetic heart valve sizer. 870.3945 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3945 Prosthetic heart valve sizer. (a) Identification. A prosthetic heart valve sizer is a device used to measure the size of...

  18. 21 CFR 870.3925 - Replacement heart valve.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of...

  19. 21 CFR 870.2400 - Vectorcardiograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vectorcardiograph. 870.2400 Section 870.2400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... produced by the heart. (b) Classification. Class II (performance standards)....

  20. 21 CFR 870.2340 - Electrocardiograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electrocardiograph. 870.2340 Section 870.2340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... produced by the heart. (b) Classification. Class II (performance standards)....

  1. 21 CFR 870.3800 - Annuloplasty ring.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Annuloplasty ring. 870.3800 Section 870.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...) Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid...

  2. 21 CFR 892.2050 - Picture archiving and communications system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Picture archiving and communications system. 892... communications system. (a) Identification. A picture archiving and communications system is a device that... processing of medical images. Its hardware components may include workstations, digitizers,...

  3. 21 CFR 870.3730 - Pacemaker service tools.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen...

  4. 21 CFR 870.3650 - Pacemaker polymeric mesh bag.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold...

  5. 21 CFR 870.3700 - Pacemaker programmers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more...

  6. 21 CFR 870.3710 - Pacemaker repair or replacement material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is...

  7. 21 CFR 808.89 - Rhode Island.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rhode Island. 808.89 Section 808.89 Food and Drugs... and Local Exemptions § 808.89 Rhode Island. The following Rhode Island medical device requirements are... from preemption under section 521(b) of the act: Rhode Island General Laws, Section 5-49-2.1,...

  8. 21 CFR 872.4465 - Gas-powered jet injector.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas-powered jet injector. 872.4465 Section 872...) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4465 Gas-powered jet injector. (a) Identification. A gas-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe...

  9. 21 CFR 872.4475 - Spring-powered jet injector.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Spring-powered jet injector. 872.4475 Section 872...) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4475 Spring-powered jet injector. (a) Identification. A spring-powered jet injector is a syringe device intended to administer a local anesthetic....

  10. 21 CFR 225.58 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 225.58 Section 225.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure...

  11. 21 CFR 888.3000 - Bone cap.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone cap. 888.3000 Section 888.3000 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3000 Bone cap. (a) Identification. A bone cap is a...

  12. 21 CFR 868.2775 - Electrical peripheral nerve stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... a device used to apply an electrical current to a patient to test the level of pharmacological... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electrical peripheral nerve stimulator. 868.2775... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2775 Electrical peripheral...

  13. 22 CFR 192.31 - Applicable benefits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Applicable benefits. 192.31 Section 192.31 Foreign Relations DEPARTMENT OF STATE HOSTAGE RELIEF VICTIMS OF TERRORISM COMPENSATION Medical Benefits for Captive Situations § 192.31 Applicable benefits. A person eligible for benefits under this...

  14. 22 CFR 192.32 - Administration of benefits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Administration of benefits. 192.32 Section 192.32 Foreign Relations DEPARTMENT OF STATE HOSTAGE RELIEF VICTIMS OF TERRORISM COMPENSATION Medical Benefits for Captive Situations § 192.32 Administration of benefits. (a)(1) A person eligible due...

  15. 22 CFR 192.33 - Dispute.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Dispute. 192.33 Section 192.33 Foreign Relations DEPARTMENT OF STATE HOSTAGE RELIEF VICTIMS OF TERRORISM COMPENSATION Medical Benefits for Captive Situations § 192.33 Dispute. Any dispute between the Office and eligible persons concerning whether...

  16. 22 CFR 192.30 - Eligibility for benefits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Eligibility for benefits. 192.30 Section 192.30 Foreign Relations DEPARTMENT OF STATE HOSTAGE RELIEF VICTIMS OF TERRORISM COMPENSATION Medical Benefits for Captive Situations § 192.30 Eligibility for benefits. A person designated as a captive or...

  17. 21 CFR 882.4600 - Leukotome.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Leukotome. 882.4600 Section 882.4600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... device used to cut sections out of the brain. (b) Classification. Class I (general controls). The...

  18. 21 CFR 882.5910 - Dura substitute.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dura substitute. 882.5910 Section 882.5910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... surrounding the brain). (b) Classification. Class II (performance standards)....

  19. 21 CFR 882.1330 - Depth electrode.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Depth electrode. 882.1330 Section 882.1330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... signals at, subsurface levels of the brain. (b) Classification. Class II (performance standards)....

  20. 21 CFR 882.1825 - Rheoencephalograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rheoencephalograph. 882.1825 Section 882.1825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... the brain) by electrical impedance methods with direct electrical connections to the scalp or...

  1. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic...

  2. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115,...

  3. 21 CFR 888.3300 - Hip joint metal constrained cemented or uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint metal constrained cemented or uncemented... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3300 Hip joint metal constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal...

  4. 21 CFR 888.3400 - Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint femoral (hemi-hip) metallic resurfacing... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. (a) Identification. A hip joint femoral...

  5. 21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint (hemi-hip) acetabular metal cemented... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis. (a) Identification. A hip joint (hemi-hip)...

  6. 21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint metal/polymer semi-constrained cemented... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer...

  7. 21 CFR 868.1400 - Carbon dioxide gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carbon dioxide gas analyzer. 868.1400 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1400 Carbon dioxide gas analyzer. (a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon...

  8. 21 CFR 868.2480 - Cutaneous carbon dioxide (PcCO2) monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cutaneous carbon dioxide (PcCO2) monitor. 868.2480... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2480 Cutaneous carbon dioxide (PcCO2) monitor. (a) Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive...

  9. 21 CFR 861.5 - Statement of policy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Statement of policy. 861.5 Section 861.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT General § 861.5 Statement of policy. In carrying out...

  10. 21 CFR 861.24 - Existing standard as a proposed standard.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Existing standard as a proposed standard. 861.24 Section 861.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT Procedures for...

  11. 21 CFR 898.12 - Performance standard.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Performance standard. 898.12 Section 898.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES § 898.12 Performance standard....

  12. 21 CFR 882.1560 - Skin potential measurement device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic...

  13. 21 CFR 872.3670 - Resin impression tray material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3670 Resin impression tray material. (a) Identification. Resin impression tray material is a device intended for use in a two-step dental mold fabricating... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Resin impression tray material. 872.3670...

  14. 21 CFR 872.3310 - Coating material for resin fillings.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3310 Coating material for resin fillings. (a) Identification. A coating material for resin fillings is a device intended to be applied to the... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Coating material for resin fillings....

  15. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3645 Subperiosteal implant material. (a) Identification. Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Subperiosteal implant material. 872.3645...

  16. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  17. 21 CFR 874.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 874.3 Section 874.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions § 874.3...

  18. 21 CFR 874.4100 - Epistaxis balloon.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Epistaxis balloon. 874.4100 Section 874.4100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4100 Epistaxis balloon. (a)...

  19. 21 CFR 874.5370 - Tongs antichoke device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tongs antichoke device. 874.5370 Section 874.5370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5370 Tongs antichoke device....

  20. 21 CFR 874.3300 - Hearing Aid.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hearing Aid. 874.3300 Section 874.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3300 Hearing Aid. (a) Identification. A...

  1. 21 CFR 874.4800 - Bone particle collector.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone particle collector. 874.4800 Section 874.4800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4800 Bone particle collector....

  2. 21 CFR 874.1820 - Surgical nerve stimulator/locator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Surgical nerve stimulator/locator. 874.1820 Section 874.1820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1820 Surgical...

  3. 21 CFR 874.4350 - Ear, nose, and throat fiberoptic light source and carrier.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat fiberoptic light source and... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4350 Ear, nose, and throat fiberoptic light source and carrier. (a) Identification. An ear, nose, and...

  4. 21 CFR 874.4760 - Nasopharyngoscope (flexible or rigid) and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nasopharyngoscope (flexible or rigid) and accessories. 874.4760 Section 874.4760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices §...

  5. 21 CFR 874.1600 - Olfactory test device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Olfactory test device. 874.1600 Section 874.1600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1600 Olfactory test device....

  6. 21 CFR 874.5840 - Antistammering device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Antistammering device. 874.5840 Section 874.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5840 Antistammering device....

  7. 21 CFR 874.4710 - Esophagoscope (flexible or rigid) and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Esophagoscope (flexible or rigid) and accessories. 874.4710 Section 874.4710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices §...

  8. 21 CFR 874.1060 - Acoustic chamber for audiometric testing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Acoustic chamber for audiometric testing. 874.1060 Section 874.1060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1060 Acoustic chamber...

  9. 21 CFR 874.1050 - Audiometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Audiometer. 874.1050 Section 874.1050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1050 Audiometer. (a) Identification....

  10. 21 CFR 874.3900 - Nasal dilator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nasal dilator. 874.3900 Section 874.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3900 Nasal dilator. (a) Identification. A...

  11. 21 CFR 874.4175 - Nasopharyngeal catheter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nasopharyngeal catheter. 874.4175 Section 874.4175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4175 Nasopharyngeal catheter....

  12. 21 CFR 874.4140 - Ear, nose, and throat bur.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat bur. 874.4140 Section 874...) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4140 Ear, nose, and throat bur. (a) Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that...

  13. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endolymphatic shunt. 874.3820 Section 874.3820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3820 Endolymphatic shunt....

  14. 21 CFR 874.4680 - Bronchoscope (flexible or rigid) and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bronchoscope (flexible or rigid) and accessories. 874.4680 Section 874.4680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4680...

  15. 21 CFR 874.3310 - Hearing aid calibrator and analysis system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hearing aid calibrator and analysis system. 874.3310 Section 874.3310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3310...

  16. 21 CFR 874.1080 - Audiometer calibration set.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Audiometer calibration set. 874.1080 Section 874.1080 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1080 Audiometer calibration set....

  17. 21 CFR 874.3760 - Sacculotomy tack (Cody tack)

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Sacculotomy tack (Cody tack) 874.3760 Section 874.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3760 Sacculotomy tack (Cody...

  18. 21 CFR 874.3305 - Wireless air-conduction hearing aid.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wireless air-conduction hearing aid. 874.3305 Section 874.3305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3305 Wireless...

  19. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular...

  20. 21 CFR 874.3330 - Master hearing aid.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Master hearing aid. 874.3330 Section 874.3330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3330 Master hearing aid. (a)...

  1. 21 CFR 874.5300 - Ear, nose, and throat examination and treatment unit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat examination and treatment... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5300 Ear, nose, and throat examination and treatment unit. (a) Identification. An ear, nose, and...

  2. 21 CFR 874.1070 - Short increment sensitivity index (SISI) adapter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Short increment sensitivity index (SISI) adapter. 874.1070 Section 874.1070 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1070...

  3. 21 CFR 874.4490 - Argon laser for otology, rhinology, and laryngology.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Argon laser for otology, rhinology, and laryngology. 874.4490 Section 874.4490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices §...

  4. 21 CFR 874.1325 - Electroglottograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electroglottograph. 874.1325 Section 874.1325 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1325 Electroglottograph. (a)...

  5. 21 CFR 874.3620 - Ear, nose, and throat synthetic polymer material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat synthetic polymer material... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3620 Ear, nose, and throat synthetic polymer material. (a) Identification. Ear, nose, and throat synthetic...

  6. 21 CFR 874.5800 - External nasal splint.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External nasal splint. 874.5800 Section 874.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5800 External nasal splint....

  7. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Laryngeal prosthesis (Taub design). 874.3730 Section 874.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal...

  8. 21 CFR 874.3375 - Battery-powered artificial larynx.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Battery-powered artificial larynx. 874.3375 Section 874.3375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3375...

  9. 21 CFR 874.5550 - Powered nasal irrigator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered nasal irrigator. 874.5550 Section 874.5550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5550 Powered nasal irrigator....

  10. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 874.9 Section 874.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT...

  11. 21 CFR 874.5350 - Suction antichoke device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Suction antichoke device. 874.5350 Section 874.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5350 Suction antichoke device....

  12. 21 CFR 874.4780 - Intranasal splint.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intranasal splint. 874.4780 Section 874.4780 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a)...

  13. 21 CFR 874.4250 - Ear, nose, and throat electric or pneumatic surgical drill.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat electric or pneumatic... AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4250 Ear, nose, and throat electric or pneumatic surgical drill. (a) Identification. An ear, nose,...

  14. 21 CFR 874.4720 - Mediastinoscope and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mediastinoscope and accessories. 874.4720 Section 874.4720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4720 Mediastinoscope...

  15. 21 CFR 874.4750 - Laryngostroboscope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Laryngostroboscope. 874.4750 Section 874.4750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4750 Laryngostroboscope. (a)...

  16. 21 CFR 874.4420 - Ear, nose, and throat manual surgical instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat manual surgical instrument... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4420 Ear, nose, and throat manual surgical instrument. (a) Identification. An ear, nose, and throat manual...

  17. 21 CFR 874.1500 - Gustometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gustometer. 874.1500 Section 874.1500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1500 Gustometer. (a) Identification....

  18. 21 CFR 808.3 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Definitions. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) Compelling local conditions includes... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Definitions. 808.3 Section 808.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  19. 21 CFR 862.3880 - Theophylline test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Theophylline test system. 862.3880 Section 862...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3880 Theophylline test system. (a) Identification. A theophylline test system is a device intended...

  20. 21 CFR 870.2600 - Signal isolation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Signal isolation system. 870.2600 Section 870.2600...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2600 Signal isolation system. (a) Identification. A signal isolation system is a device that electrically isolates the...

  1. 21 CFR 870.5900 - Thermal regulating system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thermal regulating system. 870.5900 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Therapeutic Devices § 870.5900 Thermal regulating system. (a) Identification. A thermal regulating system is an external system consisting of a device...

  2. 21 CFR 870.1290 - Steerable catheter control system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Steerable catheter control system. 870.1290... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1290 Steerable catheter control system. (a) Identification. A steerable catheter control system is a device that...

  3. 21 CFR 870.3535 - Intra-aortic balloon and control system

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intra-aortic balloon and control system 870.3535... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3535 Intra-aortic balloon and control system (a) Identification. A intra-aortic balloon and control system is a device...

  4. 21 CFR 862.3300 - Digitoxin test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Digitoxin test system. 862.3300 Section 862.3300...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3300 Digitoxin test system. (a) Identification. A digitoxin test system is a device intended to...

  5. 21 CFR 862.3320 - Digoxin test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Digoxin test system. 862.3320 Section 862.3320...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3320 Digoxin test system. (a) Identification. A digoxin test system is a device intended to...

  6. 21 CFR 866.5600 - Low-density lipoprotein immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Low-density lipoprotein immunological test system... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5600 Low-density lipoprotein immunological test system. (a) Identification. A low-density...

  7. 21 CFR 872.3840 - Endodontic silver point.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endodontic silver point. 872.3840 Section 872.3840...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3840 Endodontic silver point. (a) Identification. An endodontic silver point is a device made of silver intended for use during endodontic therapy...

  8. 21 CFR 892.1550 - Ultrasonic pulsed doppler imaging system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ultrasonic pulsed doppler imaging system. 892.1550... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1550 Ultrasonic pulsed doppler...

  9. 21 CFR 73.3126 - Titanium dioxide.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Titanium dioxide. 73.3126 Section 73.3126 Food and... ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3126 Titanium dioxide. (a) Identity and specifications. The color additive titanium dioxide (CAS Reg. No. 13463-67-7), Color Index No. 77891,...

  10. 21 CFR 872.3250 - Calcium hydroxide cavity liner.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Calcium hydroxide cavity liner. 872.3250 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3250 Calcium hydroxide cavity liner. (a) Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of...

  11. 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Smooth or threaded metallic bone fixation fastener... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3040 Smooth or threaded metallic bone fixation fastener. (a) Identification. A smooth or threaded metallic bone fixation...

  12. 21 CFR 801.4 - Meaning of intended uses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Meaning of intended uses. 801.4 Section 801.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.4 Meaning of intended uses. The words intended uses...

  13. 21 CFR 888.3570 - Knee joint femoral (hemi-knee) metallic uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femoral (hemi-knee) metallic uncemented... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis. (a) Identification. A knee joint femoral...

  14. 21 CFR 820.3 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Definitions. 820.3 Section 820.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION General Provisions § 820.3 Definitions. (a) Act means the Federal Food,...

  15. 21 CFR 820.160 - Distribution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Distribution. 820.160 Section 820.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... distribution. Where a device's fitness for use or quality deteriorates over time, the procedures shall...

  16. 21 CFR 882.5500 - Lesion temperature monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Lesion temperature monitor. 882.5500 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5500 Lesion temperature monitor. (a) Identification. A lesion temperature monitor is a device used to monitor the...

  17. 21 CFR 868.6225 - Nose clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nose clip. 868.6225 Section 868.6225 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6225 Nose clip. (a) Identification. A nose clip is a device...

  18. 21 CFR 862.3150 - Barbiturate test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Barbiturate test system. 862.3150 Section 862.3150...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3150 Barbiturate test system. (a) Identification. A barbiturate test system is a device intended...

  19. 21 CFR 862.1775 - Uric acid test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Uric acid test system. 862.1775 Section 862.1775...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.1775 Uric acid test system. (a) Identification. A uric acid test system is a device intended to...

  20. 21 CFR 862.3620 - Methadone test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Methadone test system. 862.3620 Section 862.3620...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3620 Methadone test system. (a) Identification. A methadone test system is a device intended to...