21 CFR 880.5690 — Infant Supine Sleep System
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5690
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QTG | Infant Supine Sleep System | 2 | 1 |
