The following data is part of a premarket notification filed by Vital Art And Science Incorporated with the FDA for Myvision Track Model 005.
| Device ID | K143211 |
| 510k Number | K143211 |
| Device Name: | MyVision Track Model 005 |
| Classification | Grid, Amsler |
| Applicant | VITAL ART AND SCIENCE INCORPORATED 2725 N. SPRING DR. Richardson, TX 75082 |
| Contact | Michael Bartlett |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
| Product Code | HOQ |
| CFR Regulation Number | 886.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004152705 | K143211 | 000 |