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FDA 510(k) Applications for Medical Device Product Code "QUH"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K221698
Eargo, Inc.
Eargo 5 , Eargo 6
12/21/2022
K223137
hearX SA (Pty) Ltd.
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
03/14/2023
K221052
Huizhou Jinghao Medical Technology Co., Ltd.
Self-Fitting hearing aids
09/25/2023
K221064
Nuheara Limited
Nuheara IQbuds 2 PRO Hearing Aid
10/30/2022
K230538
Sonova AG
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
06/16/2023
K223848
Tuned Ltd
IntrisoundÖ Tuned Lumen« 155 Hearing Aids
09/08/2023
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