FDA 510(k) Application Details - K033108

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K033108
Device Name	Audiometer
Applicant	VIVOSONIC, INC. 56 ABERFOYLE CRESCENT SUITE 620 TORONTO, ON M8X 2W4 CA Other 510(k) Applications for this Company
Contact	YURI SOKOLOV Other 510(k) Applications for this Contact
Regulation Number	874.1050   More FDA Info for this Regulation Number
Classification Product Code	EWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2003
Decision Date	10/27/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review