FDA 510(k) Application Details - K130987

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K130987
Device Name	Electrode, Cutaneous
Applicant	AXELGAARD MFG. CO., LTD. 520 INDUSTRIAL WAY FALLBROOK, CA 92028-2244 US Other 510(k) Applications for this Company
Contact	DAN P JEFFERY 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	04/09/2013
Decision Date	07/17/2013
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