FDA.reportPublic FDA data

De Novo DEN210039

Device
SNOO Smart Sleeper
Contact
harvey karp
De Novo number
DEN210039
Product code
QTG
Regulation
880.5690
Classification name
infant supine sleep system
Decision
granted (DENG)
Decision date
2023-03-30
Date received
2021-09-20
Classification advisory
General Hospital
Review advisory
General Hospital
Type
Direct

Current FDA Classification#

Product code
QTG
Device name
Infant Supine Sleep System
Medical specialty
General Hospital
Device class
2
Regulation
880.5690
Implant
N
Life sustain/support
N