FDA 510(k) Application Details - K152815

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K152815
Device Name	Electrode, Cutaneous
Applicant	SHENZHEN MAILUOKANG TECHNOLOGY CO., LTD. RM 602, 6/F, BUILDING B, NANCHANG JIANYU NO. 2 INDUSTRIAL ZONE, GUSHU VILLAGE SHENZHEN 518000 CN Other 510(k) Applications for this Company
Contact	HU PANDENG 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	09/28/2015
Decision Date	03/08/2016
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