FDA 510(k) Application Details - K092089

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K092089
Device Name	Audiometer
Applicant	AUDIGENCE, INC. 1050 W. NASA BLVD. SUITE 154 MELBOURNE, FL 32901 US Other 510(k) Applications for this Company
Contact	CRAIG PAGAN 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	07/09/2009
Decision Date	03/10/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review