Device Classification Name |
positive airway pressure system
|
De Novo Number |
DEN170089 |
Device Name |
Curve Positive Airway Pressure System |
Requester |
FRESCA Medical |
1291 puerta del sol, suite 200 |
san clemente,
CA
92673
|
|
Contact |
mary lou mooney |
|
Regulation Number | 868.5273
|
Classification Product Code |
|
Date Received | 12/14/2017 |
Decision Date | 06/05/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Anesthesiology
|
Review Advisory Committee |
Anesthesiology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|