The following data is part of a premarket notification filed by Vital Art And Science Incorporated with the FDA for Myvisiontrack(tm).
Device ID | K121738 |
510k Number | K121738 |
Device Name: | MYVISIONTRACK(TM) |
Classification | Grid, Amsler |
Applicant | VITAL ART AND SCIENCE INCORPORATED 2725 N. SPRING DR. Richardson, TX 75082 |
Contact | Michael Bartlett |
Correspondent | Michael Bartlett VITAL ART AND SCIENCE INCORPORATED 2725 N. SPRING DR. Richardson, TX 75082 |
Product Code | HOQ |
CFR Regulation Number | 886.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-13 |
Decision Date | 2013-02-22 |
Summary: | summary |