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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 a medical device manufactured by Eargo, Inc.. It received FDA 510(k) clearance on 2022-12-21 under approval 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. It is manufactured by Eargo, Inc.. The 510(k) number is K221698.

When was Eargo 5 , Eargo 6 approved by the FDA?

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

What company makes Eargo 5 , Eargo 6?

Eargo 5 , Eargo 6 is manufactured by Eargo, Inc..

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

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

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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.

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