FDA 510(k) Application Details - K041902

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K041902
Device Name	Electrode, Cutaneous
Applicant	MANTRA INTL. (HK) LTD. 10235 GLADE AVE. CHATSWORTH, CA 91311 US Other 510(k) Applications for this Company
Contact	ROBERT B SPERTELL 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	07/14/2004
Decision Date	09/22/2004
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