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FDA 510(k)

AUDIOSCREENER OAE+ABR

K-Number: K024205 · 2003-03-07

ApplicantEverest Biomedical Instruments Co.
Decision Date2003-03-07
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 Everest Biomedical Instruments Co.. It received FDA 510(k) clearance on 2003-03-07 under 510(k) number K024205. 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 2003-03-07. The listed applicant is Everest Biomedical Instruments Co.. The 510(k) number is K024205.

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

AUDIOSCREENER OAE+ABR received FDA 510(k) clearance on 2003-03-07, under 510(k) number K024205.

Who is the listed applicant for AUDIOSCREENER OAE+ABR?

The FDA 510(k) record lists Everest Biomedical Instruments Co. 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 Everest Biomedical Instruments Co. 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.

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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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