Device Classification Name |
thermal system for insomnia
|
De Novo Number |
DEN140032 |
Device Name |
Cereve Sleep System |
Requester |
CEREVE, INC. |
333 allegheny ave., 2nd floor north |
oakmont,
PA
15139
|
|
Contact |
eric nofzinger |
|
Regulation Number | 882.5700
|
Classification Product Code |
|
Date Received | 10/20/2014 |
Decision Date | 05/13/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|