FDA 510(k) Application Details - K182111

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K182111
Device Name	Electrode, Cutaneous
Applicant	Shaoxing DL Healthcare Co., Ltd. Jiulin Land, Baiguan Street, Shangyu District Shaoxing 312300 CN Other 510(k) Applications for this Company
Contact	Zhao Qingya 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	08/06/2018
Decision Date	01/17/2019
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