Device Classification Name |
evoked photon image capture device
|
De Novo Number |
DEN150004 |
Device Name |
EPIC ClearView System |
Requester |
epic research & diagnostics, inc. |
7659 e pinnacle peak rd. suite 115 |
scottsdale,
AZ
85255
|
|
Contact |
nancy rizzo |
|
Regulation Number | 882.1561
|
Classification Product Code |
|
Date Received | 01/13/2015 |
Decision Date | 07/15/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|