FDA 510(k) Application Details - K191083

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K191083
Device Name	Electrode, Cutaneous
Applicant	Coapt, LLC 222 W. Ontario Street, Suite #300 Chicago, IL 60654 US Other 510(k) Applications for this Company
Contact	Blair A Lock Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2019
Decision Date	05/24/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review