FDA 510(k) Application Details - K002219

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K002219
Device Name	Electrode, Cutaneous
Applicant	WANDY RUBBER INDUSTRIAL CO., LTD NO. 22, ALLAY 37, LANE 266 FU TEH I RD. SHI-CHIH, TAIPEI TW Other 510(k) Applications for this Company
Contact	JANIS YANG 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	07/24/2000
Decision Date	02/02/2001
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