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 Device, Storage, Images, Ophthalmic
510(k) Number K021787
Device Name VISUCAM
Applicant
Carl Zeiss Ophthalmic Systems, Inc.
555 Thireenth St., NW
Washington,  DC  20004 -1109
Applicant Contact DIONNE N LABATORE
Correspondent
Carl Zeiss Ophthalmic Systems, Inc.
555 Thireenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact DIONNE N LABATORE
Regulation Number892.2010
Classification Product Code
NFF  
Subsequent Product Code
NFG  
Date Received05/30/2002
Decision Date 06/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-