FDA 510(k) Application Details - K150804

Device Classification Name	Device, Galvanic Skin Response Measurement   More FDA Info for this Device
510(K) Number	K150804
Device Name	Device, Galvanic Skin Response Measurement
Applicant	MEDEIA, INC. 80 S. W. 8TH ST. SUITE 200 MIAMI, FL 33130 US Other 510(k) Applications for this Company
Contact	SLAV DANEV Other 510(k) Applications for this Contact
Regulation Number	882.1540   More FDA Info for this Regulation Number
Classification Product Code	GZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2015
Decision Date	10/19/2015
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