FDA 510(k) Application Details - K080060

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K080060
Device Name	Stimulator, Auditory, Evoked Response
Applicant	VIVOSONIC, INC. 120-5525 EGLINTON AVENUE WEST TORONTO, ON M9C 5K5 CA Other 510(k) Applications for this Company
Contact	AMJAD RANA 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	01/09/2008
Decision Date	04/04/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review