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 K092374
Device Name OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
Applicant
Ophthalmic Imaging Systems
221 Lathrop Way, Suite I
Sacramento,  CA  95815
Applicant Contact ANDREA AMBROSE
Correspondent
Ophthalmic Imaging Systems
221 Lathrop Way, Suite I
Sacramento,  CA  95815
Correspondent Contact ANDREA AMBROSE
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Codes
HJO   NFG  
Date Received08/05/2009
Decision Date 11/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-