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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K113831
Device Name PRIMUS HEARING INSTRUMENT TEST UNIT
Applicant
Auditdata A/S
Banestroeger 13
Taastrup,  DK DK-2630
Applicant Contact DAN HAUGBOL
Correspondent
Auditdata A/S
Banestroeger 13
Taastrup,  DK DK-2630
Correspondent Contact DAN HAUGBOL
Regulation Number874.3310
Classification Product Code
ETW  
Subsequent Product Code
EWO  
Date Received12/27/2011
Decision Date 04/19/2012
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
Predetermined Change
Control Plan Authorized		 No
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