FDA 510(k) Application Details - K171721

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K171721
Device Name	Electrode, Cutaneous
Applicant	Shenzhen Konmed Technology Co., Ltd 703B, Haide building A, Nanxin Road, Nanshan Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Tony Tony 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	06/12/2017
Decision Date	01/05/2018
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