QTG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Infant Supine Sleep System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5690
- Medical specialty
- General Hospital
- FDA definition
- 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).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SNOO Smart Sleeper (DEN210039) | Happiest Baby, Inc. | 2023-03-30 |
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