FDA 510(k) Application Details - K092373

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K092373
Device Name	Stimulator, Auditory, Evoked Response
Applicant	GN OTOMETRICS 333 MILFORD RD DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	882.1900   More FDA Info for this Regulation Number
Classification Product Code	GWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2009
Decision Date	09/03/2009
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