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De Novo DEN210033
- Device
- Lenire Tinnitus Treatment Device
- Contact
- fran coogan
- De Novo number
- DEN210033
- Product code
- QVN
- Regulation
- 874.3410
- Classification name
- combined acoustic and electrical external stimulation device for the relief of tinnitus
- Decision
- granted (DENG)
- Decision date
- 2023-03-06
- Date received
- 2021-08-18
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Direct
Current FDA Classification#
- Product code
- QVN
- Device name
- Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.3410
- Implant
- N
- Life sustain/support
- N