FDA 510(k) Application Details - K003154

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K003154
Device Name	Amplifier, Physiological Signal
Applicant	EB NEURO, S.P.A. 7992 CASTLEWAY DR. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	COLLEEN HITTLE Other 510(k) Applications for this Contact
Regulation Number	882.1835   More FDA Info for this Regulation Number
Classification Product Code	GWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2000
Decision Date	01/05/2001
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