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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 4-203: ANSI S3.6-2010 (Revision of ANSI S3.6-2004), specification for audiometers. (Dental/ENT)

Date of Standard: 2010. 
Address of Standards Development Organization:
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
Audiometers
Processes Affected:
510(K), PMA, PDP, IDE, HDE, Design Control Input, Quallity System Regulation
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
§874.1050 Audiometer Class 2 EWO
FDA Technical Contact:
 Shu-Chen Peng
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66 Room 2446
  Silver Spring MD 20993
  301/796-6481
  email: shu-chen.peng@fda.hhs.gov
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