FDA 510(k) Application Details - K030016

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K030016
Device Name	Audiometer
Applicant	INTERACOUSTICS A/S, ASSENS 9675 WEST 76TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	DANIEL EGGAN 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	01/02/2003
Decision Date	03/28/2003
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