Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-72: ISO 10651-5 First edition 2006-02-01, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators. (Anesthesias)
Date of Standard: 2006. |
| 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: |
| Gas-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 |
| §868.5925 |
Ventilator, Emergency, Powered (Resuscitator) |
Class 2 |
BTL |
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| Relevant Guidance: |
Reviewer Guidance for Labeling Reusabe 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: |
| Chan Lee |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2543 |
| Silver Spring MD 20993 |
| 301/796-6267 |
| Email: chan.lee@fda.hhs.gov |
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