510(k) DEN210039
DEN210039 is an FDA 510(k) premarket notification submitted by Happiest Baby, Inc. for the device "SNOO Smart Sleeper". The FDA issued a decision of De Novo Granted on March 30, 2023. The device falls under product code QTG (Infant Supine Sleep System), a Class II device regulated under 21 CFR 880.5690.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 30, 2023
- Date Received
- September 20, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infant Supine Sleep System
- Device Class
- Class II
- Regulation Number
- 880.5690
- Review Panel
- HO
- Submission Type
An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).