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 Camera, Ophthalmic, Ac-Powered
510(k) Number K111612
Device Name DIGITAL RETINAL CAMERA
Applicant
Canon, Inc.
Tokyo Office
6-5-3 Beaune Honkomagome 2f
Honkomagome, Bunkyo-Ku Tokyo,  JP 113-0021
Applicant Contact KOJI KUBO
Correspondent
Canon, Inc.
Tokyo Office
6-5-3 Beaune Honkomagome 2f
Honkomagome, Bunkyo-Ku Tokyo,  JP 113-0021
Correspondent Contact KOJI KUBO
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/09/2011
Decision Date 09/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-