FDA 510(k) Application Details - K153019

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K153019
Device Name	Electrode, Cutaneous
Applicant	BIO PROTECH, INC. DONGHWA MEDICAL INSTRUMENT COMPLEX, 151-3, DONGHWAGONGDAN-RO, MUNMAK-EUP WONJU-SI 220-801 KR Other 510(k) Applications for this Company
Contact	DANIEL WOO 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	10/15/2015
Decision Date	03/21/2016
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