FDA 510(k) Application Details - K000947

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K000947
Device Name	Electrode, Cutaneous
Applicant	AXELGAARD MFG. CO., LTD. 329 WEST AVIATION RD. FALLBROOK, CA 92028-3227 US Other 510(k) Applications for this Company
Contact	DAN 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	03/23/2000
Decision Date	06/16/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review