FDA 510(k) Application Details - K172887

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K172887
Device Name	Electrode, Cutaneous
Applicant	Guangzhou Xinbo Electronic Co., Ltd. 2nd Building, Juntuo Industry Park, XingyeDadao Nancun Town, Panyu District Guangzhou 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	09/21/2017
Decision Date	04/19/2018
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