510(k) DEN150053
- Device
- FETAL PILLOW
- Applicant
- Safe Obstetric Systems, Ltd.
- 510(k) number
- DEN150053
- Product code
- PWB
- Decision
- Unknown (DENG)
- Decision date
- 2017-07-27
- Date received
- 2015-11-18
- Regulation
- 884.4350
- Classification name
- Fetal Head Elevator
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- RAJIV VARMA
- Address
- Berkeley Townsend 150 Hutton Rd. Shenfield GB CM15 8NL CM15 8NL
FDA Registration Numbers#
- 1216677
- 3014195785
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PWB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243799 | Fetal Pillow | CooperSurgical, Inc. | 2025-08-29 |