FDA 510(k) Application Details - K192568

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K192568
Device Name	Electrode, Cutaneous
Applicant	Wuxi Jiajian Medical Instrument Co., Ltd NO.35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi 214116 CN Other 510(k) Applications for this Company
Contact	Caihong Sun 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	09/18/2019
Decision Date	02/03/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review