Recognition List Number: 028 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 Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Manually-powered ventilatory resuscitators intended for emergency use both outside and inside hospitals |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5915 |
Ventilator, Emergency, Manual (Resuscitator) |
Class 2 |
BTM |
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| 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 |
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| 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 |
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