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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 K121847
Device Name TITAN
Original Applicant
drejervaenget 8
assens,  DK dk-5610
Original Contact erik nielsen
Regulation Number874.1090
Classification Product Code
Subsequent Product Code
Date Received06/25/2012
Decision Date 11/29/2012
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