• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name perimeter, automatic, ac-powered
510(k) Number K121738
Model 0003
Device Name MYVISIONTRACK(TM)
Original Applicant
VITAL ART AND SCIENCE INCORPORATED
2725 n. spring dr.
richardson,  TX  75082
Original Contact michael bartlett
Regulation Number886.1605
Classification Product Code
HPT  
Date Received06/13/2012
Decision Date 02/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-