FDA 510(k) Application Details - K160138

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K160138
Device Name	Electrode, Cutaneous
Applicant	GMDASZ MANUFACTURING CO., LTD ROOM E1308, XIHAIMINGZHU BUILDING, TAOYUAN ROAD NANSHAN DISTRICT SHENZHEN CITY 518052 CN Other 510(k) Applications for this Company
Contact	CHARLES MACK 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	01/21/2016
Decision Date	08/11/2016
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