| Device Classification Name |
Recorder, Attention Task Performance
|
| 510(k) Number |
K170082 |
| Device Name |
Test of Variables of Attention (T.O.V.A.) Version 9.0 |
| Applicant |
| The Tova Company |
| 2828 SW Corbett Ave. |
| Suite 128 |
|
Portland,
OR
97201
|
|
| Applicant Contact |
CHRIS HOLDER |
| Correspondent |
| The Tova Company |
| 2828 SW Corbett Ave. |
| Suite 128 |
|
Portland,
OR
97201
|
|
| Correspondent Contact |
CHRIS HOLDER |
| Classification Product Code |
|
| Date Received | 01/10/2017 |
| Decision Date | 05/17/2017 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Neurology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|