FDA 510(k) Application Details - K181234

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K181234
Device Name	Electrode, Cutaneous
Applicant	Dong Guan Ou Kang Electronics CO., LTD 3rd Floor, Xiqunli building, Shipai road, Yanwo Village Shipai town Dongguan 523407 CN Other 510(k) Applications for this Company
Contact	Nianjun Liu 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	05/09/2018
Decision Date	08/07/2018
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