FDA 510(k) Application Details - K180247

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K180247
Device Name	Electrode, Cutaneous
Applicant	Daehan Medical Systems Co., Ltd. 250 Okgucheondong-Ro Siheung City 15084 KR Other 510(k) Applications for this Company
Contact	Da Pin 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	01/29/2018
Decision Date	11/01/2018
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