FDA 510(k) Application Details - K210448

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K210448
Device Name	Electrode, Cutaneous
Applicant	Shaoxing Yingtuo Healthcare Co.,Ltd. NO.176 Shungeng Road,Baiguan Street,Shangyu Area, Shaoxing City,Zhejiang Shaoxing 312300 CN Other 510(k) Applications for this Company
Contact	Haze XU 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	02/16/2021
Decision Date	08/31/2021
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