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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 019 FR Publication Date: 12/19/2007 

Part B: Supplementary Information

Recognition Number 10-37: ISO 10942 Second edition 2006-06-01, ophthalmic instruments -- direct ophthalmoscopes. (Ophthalmic)

Date of Standard: 2006. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
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:
Direct Ophthalmoscopes, AC and DC Powered
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Sections 5.5, 6.2, 7, 8 and Annexes A, B, & C
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§886.1570 Ophthalmoscope, Battery-Powered Class 2 HLJ
§886.1570 Ophthalmoscope,Laser,Scanning Class 2 MYC
Relevant Guidance:
Guidance for Industry Ophthalmoscope Guidance - (Direct and Indirect), Issued July 8, 1998
FDA Technical Contact:
 Dexiu Shi
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2246
  Silver Spring MD 20993
  301/796-6860
  email: dexiu.shi@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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