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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name self-fitting air-conduction hearing aid, prescription
510(k) Number K220403
Device Name Vibe SF Self-Fitting Hearing Aid
Nymollevej 6
Lynge,  DK 3540
Applicant Contact Kristine Klitgaard Pedersen
Hogan Lovells US LLP
Columbia Square, 555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number874.3325
Classification Product Code
Date Received02/11/2022
Decision Date 08/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT04972162
Reviewed by Third Party No
Combination Product No