FDA 510(k) Application Details - DEN170023

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170023
Device Name	ThermoNeuroModulation Device, TNM Device
Applicant	Scion NeuroStim, LLC 3105 Cone Manor Lane Raleigh, NC 27613-6606 US Other 510(k) Applications for this Company
Contact	Robert Black Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2017
Decision Date	03/26/2018
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review