• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 014 FR 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 Development 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)
Devices Affected:
Monoplace and multiplace hyperbaric chambers.
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 Vertical, National
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
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
-
-