FDA 510(k) Application Details - K131720

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K131720
Device Name	Electrode, Cutaneous
Applicant	HIVOX BIOTEK, INC. 8 F., NO. 98, SHINDE RD, SANCHONG DISTRICT NEW TAIPEI CITY 24158 TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen 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	06/12/2013
Decision Date	07/25/2014
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