FDA 510(k) Application Details - K180524

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K180524
Device Name	Electrode, Cutaneous
Applicant	EncephaloDynamics, Inc. 4320 NW 23rd Avenue, Suite 1 Gainesville, FL 32606 US Other 510(k) Applications for this Company
Contact	J. Chris Sackellares 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	02/27/2018
Decision Date	05/18/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review