Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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


New Search Back To Search Results
Device Classification Name refractor, manual, non-powered, including phoropter
510(k) Number K936205
Device Name COMPREHENSIVE PHOROPTER, MDR-680
Applicant
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Applicant Contact KOICHI YANO
Correspondent
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Correspondent Contact KOICHI YANO
Regulation Number886.1770
Classification Product Code
HKN  
Date Received12/29/1993
Decision Date 09/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-