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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K221125
Device Name SilentCloud
Applicant
Aureliym GmbH
Hauptstrasse 96
Bad Neuenahr-Ahrweiler,  DE D-53474
Applicant Contact Markus Haller
Correspondent
Aureliym GmbH
Hauptstrasse 96
Bad Neuenahr-Ahrweiler,  DE D-53474
Correspondent Contact Markus Haller
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/18/2022
Decision Date 01/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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