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FDA 510(k)

hearOAE

K-Number: K231545 · 2023-10-27

ApplicantHearx SA (Pty) , Ltd.
Decision Date2023-10-27
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

hearOAE is a medical device manufactured by Hearx SA (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-10-27 under approval 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. It is manufactured by Hearx SA (Pty) , Ltd.. The 510(k) number is K231545.

When was hearOAE approved by the FDA?

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

What company makes hearOAE?

hearOAE is manufactured by Hearx SA (Pty) , Ltd..

What is the FDA product code for hearOAE?

The FDA product code for hearOAE is EWO.

Other Devices by Hearx SA (Pty) , Ltd.

K223137Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

Related Devices (Code: EWO)

K172403GSI NovusGrason-Stadler, Inc. K171506EasyscreenMaico Diagnostics GmbH K180287GSI CortiGrason-Stadler, Inc. K173567SeraInteracoustics A/S K191372LyraInteracoustics A/S K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH

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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