FDA 510(k) Application Details - K180773

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K180773
Device Name	Electrode, Cutaneous
Applicant	Shaoxing DongZhi Electrical Technology Co., Ltd. Xinsha Village, Cao E Street, Shangyu Area Shaoxing 312352 CN Other 510(k) Applications for this Company
Contact	Haze XU 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	03/23/2018
Decision Date	05/22/2018
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