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 K982689
Device Name WINSTATION RETINAL IMAGER
Applicant
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Applicant Contact BETH A SOPER
Correspondent
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Correspondent Contact BETH A SOPER
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/03/1998
Decision Date 10/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-