Device Classification Name |
Grid, Amsler
|
510(k) Number |
K143211 |
Device Name |
myVision Track Model 005 |
Applicant |
VITAL ART AND SCIENCE INCORPORATED |
2725 N. SPRING DR. |
RICHARDSON,
TX
75082
|
|
Applicant Contact |
Michael Bartlett |
Correspondent |
O'Connell Regulatory Consultants, Inc. |
5 Timber Lane |
North Reading,
MA
01864
|
|
Correspondent Contact |
Maureen O'Connell |
Regulation Number | 886.1330
|
Classification Product Code |
|
Date Received | 11/10/2014 |
Decision Date | 03/20/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|