FDA 510(k) Application Details - K151693

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K151693
Device Name	Electrode, Cutaneous
Applicant	DRTV ASIA LTD 2ND BUILDING, JUNTUO INDUSTRY PARK, XINYE DADAO, NANCUN PANYU 511442 CN Other 510(k) Applications for this Company
Contact	MICHAEL HO 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	06/23/2015
Decision Date	10/09/2015
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