The following data is part of a De Novo classification by Safe Obstetric Systems Ltd with the FDA for Fetal Pillow.
| DeNovo ID | DEN150053 |
| Device Name: | FETAL PILLOW |
| Classification | Fetal Head Elevator |
| Applicant | SAFE OBSTETRIC SYSTEMS LTD berkeley Townsend 150 Hutton Road Shenfield, GB Cm15 8nl |
| Contact | Rajiv Varma |
| Product Code | PWB |
| CFR Regulation Number | 884.4350 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Obstetrics/Gynecology |
| Classification Advisory | Obstetrics/Gynecology |
| Type | Direct |
| Date Received | 2015-11-18 |
| Decision Date | 2017-07-27 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |