FDA 510(k) Application Details - K211839

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K211839
Device Name	Electrode, Cutaneous
Applicant	Electrode Market Co.,Ltd. 205, Manhae-ro, Danwon-gu, A-dong 717 ho Ansan-Si 15421 KR Other 510(k) Applications for this Company
Contact	Seolmin Jeong 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	06/14/2021
Decision Date	07/28/2021
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