FDA 510(k) Application Details - K220448

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K220448
Device Name	Electrode, Cutaneous
Applicant	Shenzhen Med-link Electronics Tech Co., Ltd. 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Yi 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	02/16/2022
Decision Date	01/19/2023
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