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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 10-73: ANSI Z80.21-2010, american national standard for ophthalmics - instruments - general - purpose clinical visual acuity charts. (Ophthalmic)

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)
Devices Affected:
Visual Acuity Charts
Processes Affected:
510(k), IDE, pre-IDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§886.1150 Chart, Visual Acuity Class 1 HOX
FDA Technical Contact:
 Bruce Drum, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2418
  Silver Spring MD 20993
  301/796-6466
  email: bruce.drum@fda.hhs.gov
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