ThermoNeuroModulation Device, TNM Device
FDA 510(k) clearance DEN170023 · decided 2018-03-26
Clearance details
- K-number
- DEN170023
- Device name
- ThermoNeuroModulation Device, TNM Device
- Applicant
- Scion Neurostim, LLC
- Decision
- Unknown
- Date received
- 2017-04-17
- Decision date
- 2018-03-26
- Days to decision
- 343 days
- Clearance type
- Direct
- Product code
- QAR
- Device class
- 2
- Regulation number
- 882.5893
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.