Device Classification Name |
isocapnic ventilation device
|
De Novo Number |
DEN170044 |
Device Name |
ClearMate |
Requester |
thornhill research, inc. |
210 dundas st. w. |
toronto,
CA
m5g 2e8
|
|
Contact |
kipton lade |
|
Regulation Number | 868.5480
|
Classification Product Code |
|
Date Received | 08/18/2017 |
Decision Date | 03/14/2019 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General Hospital
|
Review Advisory Committee |
Anesthesiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|