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 K132987
Device Name COBRA FUNDUS CAMERA
Applicant
C.S.O. S.R.L.
110 E. Granada Blvd., Suite 209
Ormond Beach,  FL  32716
Applicant Contact Claude Berthoin
Correspondent
C.S.O. S.R.L.
110 E. Granada Blvd., Suite 209
Ormond Beach,  FL  32716
Correspondent Contact Claude Berthoin
Regulation Number886.1120
Classification Product Code
HKI  
Date Received09/24/2013
Decision Date 07/03/2014
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
-
-