FDA 510(k) Application Details - K112052

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K112052
Device Name	Stimulator, Electrical, Evoked Response
Applicant	CAREFUSION 209, INC. 1850 Deming Way Middleton, WI 53562 US Other 510(k) Applications for this Company
Contact	ROBERT BURDGE 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	07/18/2011
Decision Date	03/15/2012
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