FDA 510(k)

Nuheara IQbuds 2 PRO Hearing Aid

K-Number: K221064 · 2022-10-30

Decision Date2022-10-30

Product CodeQUH

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Nuheara IQbuds 2 PRO Hearing Aid is a medical device manufactured by Nuheara Limited. It received FDA 510(k) clearance on 2022-10-30 under approval number K221064. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nuheara IQbuds 2 PRO Hearing Aid?

Nuheara IQbuds 2 PRO Hearing Aid is a medical device that received FDA 510(k) clearance on 2022-10-30. It is manufactured by Nuheara Limited. The 510(k) number is K221064.

When was Nuheara IQbuds 2 PRO Hearing Aid approved by the FDA?

Nuheara IQbuds 2 PRO Hearing Aid received FDA 510(k) clearance on 2022-10-30, under approval number K221064.

What company makes Nuheara IQbuds 2 PRO Hearing Aid?

Nuheara IQbuds 2 PRO Hearing Aid is manufactured by Nuheara Limited.

What is the FDA product code for Nuheara IQbuds 2 PRO Hearing Aid?

The FDA product code for Nuheara IQbuds 2 PRO Hearing Aid is QUH.

Related Devices (Code: QUH)

K221698Eargo 5 , Eargo 6Eargo, Inc. K231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLC K221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd. K223848Intrisound Tuned Lumen® 155 Hearing AidsTuned , Ltd. K230538All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidSonova AG K223137Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationHearx SA (Pty) , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.