FDA 510(k) Application Details - K012463

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K012463
Device Name	Electrode, Cutaneous
Applicant	EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL.NO.5 LN.155 BEI-SHEND RD. SEC. 3 SHEN KENG HSIANG,TAIPEI HSIEN 222 TW Other 510(k) Applications for this Company
Contact	ROBERT TU 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	08/01/2001
Decision Date	02/05/2002
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