FDA 510(k) Application Details - K152648

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K152648
Device Name	Electrode, Cutaneous
Applicant	Suzhou Ennova Electronics Technology Co.,Ltd Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou 215124 CN Other 510(k) Applications for this Company
Contact	N/A N/A 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	09/16/2015
Decision Date	02/18/2016
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