FDA 510(k) Application Details - K121996

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K121996
Device Name	Amplifier, Physiological Signal
Applicant	EB NEURO, S.P.A. 9001 WESLEYAN ROAD INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	Allison Scott 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	07/09/2012
Decision Date	08/03/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review