De Novo
DEN150053: FETAL PILLOW
FDA De Novo · safe obstetric systems ltd · decided Jul 27, 2017
Key facts
| De Novo number | DEN150053 |
|---|---|
| Device name | FETAL PILLOW |
| Applicant | safe obstetric systems ltd |
| Product code | PWB |
| Date received | Nov 18, 2015 |
| Decision date | Jul 27, 2017 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Obstetrics/Gynecology |
| FEI number | 1216677 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None 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: