Skip to contentDe Novo DEN220025
- Device
- Phagenyx System
- Contact
- conor mulrooney
- De Novo number
- DEN220025
- Product code
- QQG
- Regulation
- 874.5950
- Classification name
- oropharyngeal electrical stimulator
- Decision
- granted (DENG)
- Decision date
- 2022-09-16
- Date received
- 2022-04-19
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Direct
Current FDA Classification#
- Product code
- QQG
- Device name
- Oropharyngeal Electrical Stimulator
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.5950
- Implant
- N
- Life sustain/support
- N