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 Keratoscope, Ac-Powered
510(k) Number K890687
Device Name ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER
Applicant
Optimed, Inc.
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Applicant Contact DOUGLAS DONALDSON
Correspondent
Optimed, Inc.
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Correspondent Contact DOUGLAS DONALDSON
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received02/09/1989
Decision Date 09/05/1989
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
-
-