510(k) DEN170023
- Device
- ThermoNeuroModulation Device, TNM Device
- Applicant
- Scion Neurostim, LLC
- 510(k) number
- DEN170023
- Product code
- QAR
- Decision
- Unknown (DENG)
- Decision date
- 2018-03-26
- Date received
- 2017-04-17
- Regulation
- 882.5893
- Classification name
- Thermal Vestibular Stimulator For Headache
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Robert Black
- Address
- 3105 Cone Manor Ln. Raleigh NC US 27613 27613
Source Documents#
510(k) summary PDF not indicated by FDA