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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