Device Classification Name |
computerized cognitive assessment aid
|
De Novo Number |
DEN130033 |
Device Name |
COGNIVUE |
Requester |
cerebral assessment systems, inc |
10 pond view drive |
pittsford,
NY
14534
|
|
Contact |
charles j duffy |
|
Regulation Number | 882.1470
|
Classification Product Code |
|
Date Received | 06/12/2013 |
Decision Date | 06/05/2015 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|