Device Classification Name |
device for sleep apnea testing based on mandibular movement
|
De Novo Number |
DEN210015 |
Device Name |
Sunrise Sleep Disorder Diagnostic Aid |
Requester |
Sunrise |
chaussée de marche 569/13 |
namur,
BE
5101
|
|
Contact |
francois naye |
|
Regulation Number | 868.2376
|
Classification Product Code |
|
Date Received | 04/02/2021 |
Decision Date | 01/07/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Ear Nose & Throat
|
Review Advisory Committee |
Anesthesiology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|