Recognition List Number: 014 Publication Date: 03/31/2006
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-67: NFPA 99:2005, Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities. (Anesthesias)
Date of Standard: 2005. |
| Address of Standards Organization: |
| National Fire Protection Association (NFPA) |
| One Batterymarch Park |
| P.O. Box 9101 |
| Quincy, MA 02269-9101 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Monoplace and multiplace hyperbaric chambers. |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
| Complete Standard and any annexes. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5470 |
Chamber, Hyperbaric |
Class 2 |
CBF |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Christy Foreman |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1676 |
| Silver Spring MD 20993 |
| 301/796-6382 |
| Email: christy.foreman@fda.hhs.gov |
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