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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 K162210
Device Name touchTymp
Applicant
Maico Diagnostics GmbH
Sickingenstr. 70-71
Berlin,  DE 10553
Applicant Contact UWE LEDWORUSKI
Correspondent
Maico Diagnostics GmbH
Sickingenstr. 70-71
Berlin,  DE 10553
Correspondent Contact UWE LEDWORUSKI
Regulation Number874.1090
Classification Product Code
ETY  
Date Received08/05/2016
Decision Date 11/16/2016
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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