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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 1-69: ASTM F1464-93 (Reapproved 2005), standard specification for oxygen concentrators for domiciliary use. (Anesthesias)

Date of Standard: 1993. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
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:
Oxygen concentrators excluding those intended to supply gas to several patients via a piped medical gas installation or those intended for use in the presence of flammable anesthetic or cleaning agents or both.
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard with the following exceptions:

Clause 36 Electromagnetic Compatibility is not recognized
Clause 42.1 Amendment is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5440 Generator, Oxygen, Portable Class 2 CAW
FDA Technical Contact:
 Amy Levelle
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2547
  Silver Spring MD 20993
  301/796-6963
  email: amy.levelle@fda.hhs.gov
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