FDA 510(k)

hearOAE

K-Number: K231545 · 2023-10-27

Decision Date2023-10-27

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

hearOAE is the device name listed in this FDA 510(k) record. The listed applicant is Hearx SA (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K231545. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the hearOAE?

hearOAE is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Hearx SA (Pty) , Ltd.. The 510(k) number is K231545.

When did hearOAE receive FDA 510(k) clearance?

hearOAE received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231545.

Who is the listed applicant for hearOAE?

The FDA 510(k) record lists Hearx SA (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for hearOAE?

The FDA product code for hearOAE is EWO.

Other records listing Hearx SA (Pty) , Ltd. as applicant

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.

K223137Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

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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.