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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, auditory, evoked response
510(k) Number K122067
Device Name TYPE 1077 ACCUSCREEN
Original Applicant
hoerskaetten 9
taatrup,  DA dk-2630
Original Contact tom riniker
Regulation Number882.1900
Classification Product Code
Date Received07/16/2012
Decision Date 09/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No