QTG · Infant Supine Sleep System
General Hospital · 21 CFR 880.5690 · Class 2
Overview
| Product Code | QTG |
|---|---|
| Device Name | Infant Supine Sleep System |
| Regulation | 21 CFR 880.5690 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
The SNOO Smart Sleeper is an infant supine sleep system comprised of a bassinet and a sleep sack that jointly constitute an infant securement device intended to facilitate a supine position during sleep. It is intended for home use by caregivers of infants from birth to 6 months of age who are not yet able to roll over consistently.
Classification Rationale
Class II (special controls). The device is subject to the general controls of the FD&C Act and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the infant supine sleep system is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN210039 | SNOO Smart Sleeper | Happiest Baby, Inc. | Mar 30, 2023 | DENG |
Top Applicants
- Happiest Baby, Inc. — 1 clearance
