FDA 510(k) Application Details - K192764

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K192764
Device Name	Electrode, Cortical
Applicant	NeuroOne, Inc. 10901 Red Circle Dr., Suite 150 Minnetonka, MN 55343 US Other 510(k) Applications for this Company
Contact	Debra Kridner 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	09/30/2019
Decision Date	11/26/2019
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