De Novo DEN200006
- Device
- ClearUP Sinus Relief
- Contact
- michael nketiah
- De Novo number
- DEN200006
- Product code
- QNU
- Regulation
- 874.6000
- Classification name
- transcutaneous electrical nerve stimulator for the relief of congestion
- Decision
- granted (DENG)
- Decision date
- 2021-03-05
- Date received
- 2020-02-07
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Direct
Current FDA Classification#
- Product code
- QNU
- Device name
- Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.6000
- Implant
- N
- Life sustain/support
- N