FDA 510(k) Application Details - K190118

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K190118
Device Name	Electrode, Cutaneous
Applicant	Guangzhou Xinbo Electronic Co., Ltd. 23 Building, Phase-II Huachuang Industry Park Panyu 511400 CN Other 510(k) Applications for this Company
Contact	Sammy Li 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	01/24/2019
Decision Date	05/13/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review