DEN210039 is an FDA 510(k) submission for the SNOO Smart Sleeper. This device is classified as a Infant Supine Sleep System (Class II - Special Controls, product code QTG).
Submitted by Happiest Baby, Inc. (Los Angeles, US). The FDA issued a Not Cleared (DENG) decision on March 30, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5690. 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)..
| 510(k) Number | DEN210039 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 20, 2021 |
| Decision Date | March 30, 2023 |
| Days to Decision | 556 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | QTG - Infant Supine Sleep System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5690 |
| 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). |