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 Stimulator, Photic, Evoked Response
510(k) Number K120104
Device Name VISIONSEARCH 1
Applicant
Visionsearch Pty, Ltd.
460 Pacific Highway
Suite 408
St Leonards,  AU 2074
Applicant Contact ARTHUR BRANDWOOD
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Regulation Number882.1890
Classification Product Code
GWE  
Date Received01/13/2012
Decision Date 05/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-