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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K213345
Device Name Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
Applicant
Path Medical GmbH
Landsberger Strasse 65
Germering,  DE 82110
Applicant Contact Johann Oswald
Correspondent
Path Medical GmbH
Landsberger Strasse 65
Germering,  DE 82110
Correspondent Contact Johann Oswald
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Codes
ETY   GWJ  
Date Received10/08/2021
Decision Date 06/22/2022
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
Recalls CDRH Recalls
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