FDA 510(k) Application Details - K213170

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K213170
Device Name	Electrode, Depth
Applicant	Sensomedical Labs LTD Nazareth Industrtial Park Nazareth 1612102 IL Other 510(k) Applications for this Company
Contact	Sama Tarazi Other 510(k) Applications for this Contact
Regulation Number	882.1330   More FDA Info for this Regulation Number
Classification Product Code	GZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2021
Decision Date	04/18/2023
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