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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K083861
Device Name TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
Applicant
Interacoustics AS
Drejervaenget 8
Assens,  DK DK-5610
Applicant Contact HANNE NIELSEN
Correspondent
Interacoustics AS
Drejervaenget 8
Assens,  DK DK-5610
Correspondent Contact HANNE NIELSEN
Regulation Number874.1090
Classification Product Code
ETY  
Date Received12/24/2008
Decision Date 04/09/2009
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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