FDA 510(k) Application Details - K012140

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K012140
Device Name	Electrode, Cutaneous
Applicant	APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET HSI-CHIH CITY, TAIPEI HSIEN TW Other 510(k) Applications for this Company
Contact	ALAN CHANG 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	07/10/2001
Decision Date	10/05/2001
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