FDA 510(k) Application Details - K233293

Device Classification Name	More FDA Info for this Device
510(K) Number	K233293
Device Name	Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System«
Applicant	NeuroSigma, Inc. 10960 Wilshire Blvd., Suite 1910 Los Angeles, CA 90024 US Other 510(k) Applications for this Company
Contact	Colin P. Kealey, M.D. Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	01/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review