FDA 510(k) Application Details - K222453

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K222453
Device Name	Electrode, Cutaneous
Applicant	Guangdong Comytens Medical Technology Co., Ltd Building A-102, No. 24, Jiangjunmao Industriual Zone Wulian, Longgang District Shenzhen 518116 CN Other 510(k) Applications for this Company
Contact	Mr. Deng Jiuzhen 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	08/15/2022
Decision Date	11/04/2022
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