FDA 510(k) Application Details - K191186

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K191186
Device Name	Electrode, Cortical
Applicant	Ad-Tech Medical Instrument Corporation 400 West Oakview Parkway Oak Creek, WI 53154 US Other 510(k) Applications for this Company
Contact	Lisa Theama Other 510(k) Applications for this Contact
Regulation Number	882.1310   More FDA Info for this Regulation Number
Classification Product Code	GYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2019
Decision Date	01/25/2020
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