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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
Model TITAN WITH IMP440 WBT
Device Name TITAN
Original Applicant
INTERACOUSTICS A/S
drejervaenget 8
assens,  DA dk-5610
Original Contact erik nielsen
Regulation Number874.1090
Classification Product Code
ETY  
Subsequent Product Code
GWJ  
Date Received06/25/2012
Decision Date 11/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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