Device Classification Name |
infant supine sleep system
|
De Novo Number |
DEN210039 |
Device Name |
SNOO Smart Sleeper |
Requester |
Happiest Baby, Inc. |
3115 s. la cienega blvd. |
los angeles,
CA
90016
|
|
Contact |
harvey karp |
|
Regulation Number | 880.5690
|
Classification Product Code |
|
Date Received | 09/20/2021 |
Decision Date | 03/30/2023 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General Hospital
|
Review Advisory Committee |
General Hospital
|
Reclassification Order |
Reclassification Order
|
Type |
Direct
|
|
|