De Novo
DEN210039: SNOO Smart Sleeper
FDA De Novo · happiest baby, inc. · decided Mar 30, 2023
Key facts
| De Novo number | DEN210039 |
|---|---|
| Device name | SNOO Smart Sleeper |
| Applicant | happiest baby, inc. |
| Product code | QTG |
| Date received | Sep 20, 2021 |
| Decision date | Mar 30, 2023 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
| FEI number | 3030187577 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: