FDA 510(k) Application Details - K150220

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K150220
Device Name	Stimulator, Electrical, Evoked Response
Applicant	EB NEURO, S.P.A. VIA PIETRO FANFANI 97/A FLORENCE 50127 IT Other 510(k) Applications for this Company
Contact	Christiano Pineider Other 510(k) Applications for this Contact
Regulation Number	882.1870   More FDA Info for this Regulation Number
Classification Product Code	GWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2015
Decision Date	08/19/2015
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