FDA 510(k) Application Details - K103298

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K103298
Device Name	Audiometer
Applicant	ACOUSTICON GMBH 1983 Hazelwood Road TOMS RIVER, NJ 08754 US Other 510(k) Applications for this Company
Contact	Maureen Garner 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	11/08/2010
Decision Date	04/08/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review