FDA 510(k) Application Details - K223276

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K223276
Device Name	Electrode, Depth
Applicant	Ad-Tech Medical Instrument Corporation 400 West Oakview Parkway Oak Creek, WI 53154-7213 US Other 510(k) Applications for this Company
Contact	Brendan McCrea 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	10/24/2022
Decision Date	05/18/2023
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