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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Air-Conduction Hearing Aid Software
510(k) Number K251208
Device Name Tuned Self-Fitting Mobile App
Applicant
Tuned , Ltd.
18 Harimon St.
Gan Yoshiya,  IL 3885000
Applicant Contact Omri Gavish
Correspondent
ProMedoss, Inc.
6026 Beech Cove Ln.
Charlotte,  NC  28269
Correspondent Contact Shoshana Friedman
Classification Product Code
SCR  
Date Received04/18/2025
Decision Date 09/26/2025
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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