Device Classification Name |
computerized cognitive assessment aid for concussion
|
De Novo Number |
DEN150037 |
Device Name |
ImPACT Computerized Neurocognitive Concussion Management Aid |
Requester |
impact applications, inc. |
2000 technology drive, suite 150 |
pittsburgh,
PA
15219
|
|
Contact |
michael zagorski |
|
Regulation Number | 882.1471
|
Classification Product Code |
|
Date Received | 08/11/2015 |
Decision Date | 08/22/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|