FDA 510(k) Application Details - K132957

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K132957
Device Name	Stimulator, Auditory, Evoked Response
Applicant	GN OTOMETRICS 8870 RAVELLO CT NAPLES, FL 34114 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM, P.E. 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	09/20/2013
Decision Date	02/27/2014
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