FDA 510(k) Application Details - K070696

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K070696
Device Name	Stimulator, Auditory, Evoked Response
Applicant	INTERACOUSTICS A/S 7625 GOLDEN TRIANGLE DRIVE EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	DANIEL EGGAN 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	03/13/2007
Decision Date	06/29/2007
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