De Novo DEN150053
- Device
- FETAL PILLOW
- Contact
- rajiv varma
- De Novo number
- DEN150053
- Product code
- PWB
- Regulation
- 884.4350
- Classification name
- fetal head elevator
- Decision
- granted (DENG)
- Decision date
- 2017-07-27
- Date received
- 2015-11-18
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Obstetrics/Gynecology
- Type
- Direct
Current FDA Classification#
- Product code
- PWB
- Device name
- Fetal Head Elevator
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 884.4350
- Implant
- N
- Life sustain/support
- N