Skip to contentDe Novo DEN170023
- Device
- ThermoNeuroModulation Device, TNM Device
- Contact
- robert black
- De Novo number
- DEN170023
- Product code
- QAR
- Regulation
- 882.5893
- Classification name
- thermal vestibular stimulator for headache
- Decision
- granted (DENG)
- Decision date
- 2018-03-26
- Date received
- 2017-04-17
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QAR
- Device name
- Thermal Vestibular Stimulator For Headache
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5893
- Implant
- N
- Life sustain/support
- N