Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-78: ASME PVHO-1-2007, Safety Standard for Pressure Vessels for Human Occupancy. (Anesthesias)
Date of Standard: 2007. |
| Address of Standards Organization: |
| American Society of Mechanical Engineers (ASME) |
| 345 East 47th Street |
| New York, NY 10017-2392 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Monoplace and multiplace hyperbaric chambers |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete standard. In addition to the statement of conformance, the following forms should be supplied in the submission:
ASME PVHO-1
ASME PVHO-1S
ASME PVHO-2
Appendix A Enclosure 1
Appendix A Enclosure 2
Appendix A Enclosure 3
Appendix A Enclosure 4 |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5470 |
Chamber, Hyperbaric |
Class 2 |
CBF |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| 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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