FDA 510(k) Application Details - K130795

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K130795
Device Name	Audiometer
Applicant	INTERACOUSTICS A/S DREJERVAENGET 8 ASSENS DK-5610 DK Other 510(k) Applications for this Company
Contact	ERIK NIELSEN 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	03/22/2013
Decision Date	06/20/2013
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