FDA 510(k) Application Details - K213884

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K213884
Device Name	Electrode, Cutaneous
Applicant	Shenzhen Changke Connect Electronics Co., Ltd. A1-2nd and A2 4th floor of factory building, No.87 of Hengping Road, Baoan Community, Yuanshan Shenzhen 518115 CN Other 510(k) Applications for this Company
Contact	Yahui Zhou 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	12/13/2021
Decision Date	05/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review