Device Classification Name |
high flow/high velocity humidified oxygen delivery device
|
De Novo Number |
DEN170001 |
Device Name |
Precision Flow® HVNI |
Requester |
vapotherm, inc. |
22 industrial dr. |
exeter,
NH
03833
|
|
Contact |
som kovvuri |
|
Regulation Number | 868.5454
|
Classification Product Code |
|
Date Received | 01/03/2017 |
Decision Date | 04/10/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Anesthesiology
|
Review Advisory Committee |
Anesthesiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|