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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K130795
Device Name TITAN
Applicant
Interacoustics A/S
Drejervaenget 8
Assens,  DK DK-5610
Applicant Contact ERIK NIELSEN
Correspondent
Interacoustics A/S
Drejervaenget 8
Assens,  DK DK-5610
Correspondent Contact ERIK NIELSEN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received03/22/2013
Decision Date 06/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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