QTG — Infant Supine Sleep System Class II
FDA product code QTG covers "Infant Supine Sleep System", a Class II medical device regulated under 21 CFR 880.5690. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QTG
- Device Class
- Class II
- Regulation Number
- 880.5690
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210039 | happiest baby | SNOO Smart Sleeper | March 30, 2023 |