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FDA 510(k)

Eargo 5 , Eargo 6

K-Number: K221698 · 2022-12-21

ApplicantEargo, Inc.
Decision Date2022-12-21
Product CodeQUH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Eargo 5 , Eargo 6 is the device name listed in this FDA 510(k) record. The listed applicant is Eargo, Inc.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K221698. 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 Eargo 5 , Eargo 6?

Eargo 5 , Eargo 6 is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Eargo, Inc.. The 510(k) number is K221698.

When did Eargo 5 , Eargo 6 receive FDA 510(k) clearance?

Eargo 5 , Eargo 6 received FDA 510(k) clearance on 2022-12-21, under 510(k) number K221698.

Who is the listed applicant for Eargo 5 , Eargo 6?

The FDA 510(k) record lists Eargo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eargo 5 , Eargo 6?

The FDA product code for Eargo 5 , Eargo 6 is QUH.

Related Devices (Code: QUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)GN Hearing A/SK233747Concha Sol Hearing Aids (CL-1001)Concha LabsK233464WSA Self-Fitting Hearing Aid Gen 2Wsaud A/SK231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLCK221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.K223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned , Ltd.

Official Source

View on FDA Database →

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

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