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 K062416
Device Name RETINAL FUNCTIONAL IMAGER (RFI)
Applicant
OPTICAL IMAGING LTD.
555 THIRTEENTH ST. NW
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
OPTICAL IMAGING LTD.
555 THIRTEENTH ST. NW
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HLI  
Date Received08/17/2006
Decision Date 11/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-