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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

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 Development Organization:
 American Society of Mechanical Engineers (ASME)
  345 East 47th Street
  New York, NY 10017-2392
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID)
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
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5470 Chamber, Hyperbaric Class 2 CBF
FDA Technical Contact:
 Nayan Patel
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2550
  Silver Spring MD 20993
  301/796-4110
  email: nayan.patel@fda.hhs.gov
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