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FDA 510(k)

AUDIOSCREENER OAE + ABR

K-Number: K001058 · 2000-06-02

ApplicantKedly, Inc.
Decision Date2000-06-02
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOSCREENER OAE + ABR is the device name listed in this FDA 510(k) record. The listed applicant is Kedly, Inc.. It received FDA 510(k) clearance on 2000-06-02 under 510(k) number K001058. 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 AUDIOSCREENER OAE + ABR?

AUDIOSCREENER OAE + ABR is a medical device that received FDA 510(k) clearance on 2000-06-02. The listed applicant is Kedly, Inc.. The 510(k) number is K001058.

When did AUDIOSCREENER OAE + ABR receive FDA 510(k) clearance?

AUDIOSCREENER OAE + ABR received FDA 510(k) clearance on 2000-06-02, under 510(k) number K001058.

Who is the listed applicant for AUDIOSCREENER OAE + ABR?

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

What is the FDA product code for AUDIOSCREENER OAE + ABR?

The FDA product code for AUDIOSCREENER OAE + ABR is EWO.

Related Clinical Trials

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.

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Other records listing Kedly, Inc. 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.

K000184AUDIOSCREENER OAE

Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

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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