FDA 510(k) Application Details - K234080

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K234080
Device Name	Stimulator, Electrical, Evoked Response
Applicant	Soterix Medical, Inc. 1480 U.S. Highway 9 North Suite 204 Woodbridge, NJ 07095 US Other 510(k) Applications for this Company
Contact	Danielle Dadona Other 510(k) Applications for this Contact
Regulation Number	882.1870   More FDA Info for this Regulation Number
Classification Product Code	GWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2023
Decision Date	03/25/2024
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