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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 K161707
Device Name Madsen Zodiac
Applicant
Gn Otometrics
Hoerskaetten 9
Taastrup,  DK DK-2630
Applicant Contact Asif Muhammad
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number874.1090
Classification Product Code
ETY  
Date Received06/21/2016
Decision Date 09/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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