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 Number | 886.1330
|
Classification Product Code |
|
Date Received | 06/13/2012 |
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
|
|
|