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ThermoNeuroModulation Device, TNM Device

DEN170023 Class II Direct
Decision Date
2018-03-26
Sponsor / Applicant
Scion Neurostim, LLC

Technical Specification

510(k) Submission ID DEN170023
Product Code QAR
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5893
Decision Date 2018-03-26
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ThermoNeuroModulation Device, TNM Device received FDA 510(k) clearance under submission number DEN170023, sponsored by Scion Neurostim, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-03-26.

Classification & Regulation

This clearance is catalogued under FDA product code QAR and 21 CFR 882.5893, within the Neurology review panel as a Class II device.