FDA 510(k) Application Details - K200162

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K200162
Device Name	Electrode, Cutaneous
Applicant	Wuhan Greentek Pty Ltd. Rm 03-2, Flr. 3, Dingye Bldg, Phase III Intl Enterprise Ctr. Special No.1 Guanggu Ave Donghu New Technology Dev. Zone Wuhan 430074 CN Other 510(k) Applications for this Company
Contact	Yarong 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	01/22/2020
Decision Date	04/21/2020
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