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 Grid, Amsler
510(k) Number K121738
Device Name MYVISIONTRACK(TM)
Applicant
Vital Art and Science Incorporated
2725 N. Spring Dr.
Richardson,  TX  75082
Applicant Contact MICHAEL BARTLETT
Correspondent
Vital Art and Science Incorporated
2725 N. Spring Dr.
Richardson,  TX  75082
Correspondent Contact MICHAEL BARTLETT
Regulation Number886.1330
Classification Product Code
HOQ  
Date Received06/13/2012
Decision Date 02/22/2013
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
-
-