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 Lens, Fundus, Hruby, Diagnostic
510(k) Number K897186
Device Name LASER IMAGING WORK STATION
Applicant
Innovision Medical, Inc.
P.O. Box 40813
Washington,  DC  20016
Applicant Contact L MACKEEN,PHD
Correspondent
Innovision Medical, Inc.
P.O. Box 40813
Washington,  DC  20016
Correspondent Contact L MACKEEN,PHD
Regulation Number886.1395
Classification Product Code
HJI  
Date Received12/28/1989
Decision Date 03/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-