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 ophthalmoscope, ac-powered
510(k) Number K030433
Device Name STRATUSOCT WITH RNFL NORMATIVE DATABASE
Applicant
CARL ZEISS MEDITEC INC
5160 HACIENDA DR.
DUBLIN,  CA  94568
Applicant Contact R. MICHAEL CROMPTON
Correspondent
CARL ZEISS MEDITEC INC
5160 HACIENDA DR.
DUBLIN,  CA  94568
Correspondent Contact R. MICHAEL CROMPTON
Regulation Number886.1570
Classification Product Code
HLI  
Date Received02/10/2003
Decision Date 05/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-