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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 1-73: ISO 10651-4 First edition 2002-03-01, lung ventilators - part 4: particular requirements for operator powered resuscitators. (Anesthesias)

Date of Standard: 2002. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Manually-powered ventilatory resuscitators intended for emergency use both outside and inside hospitals
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5915 Ventilator, Emergency, Manual (Resuscitator) Class 2 BTM
Relevant Guidance:
Reviewer Guidance for Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities, April 1996

Draft Emergency Resuscitator Guidance, April 1993

Draft Reviewer Guidance for Ventilators, July 1995
FDA Technical Contact:
 Bahram Parvinian
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2534
  Silver Spring MD 20993
  301/796-6445
  email: bahram.parvinian@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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