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FDA 510(k)

TEOAE25

K-Number: K030016 · 2003-03-28

ApplicantInteracoustics A/S, Assens
Decision Date2003-03-28
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TEOAE25 is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S, Assens. It received FDA 510(k) clearance on 2003-03-28 under 510(k) number K030016. 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 TEOAE25?

TEOAE25 is a medical device that received FDA 510(k) clearance on 2003-03-28. The listed applicant is Interacoustics A/S, Assens. The 510(k) number is K030016.

When did TEOAE25 receive FDA 510(k) clearance?

TEOAE25 received FDA 510(k) clearance on 2003-03-28, under 510(k) number K030016.

Who is the listed applicant for TEOAE25?

The FDA 510(k) record lists Interacoustics A/S, Assens as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEOAE25?

The FDA product code for TEOAE25 is EWO.

Related Clinical Trials

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Other records listing Interacoustics A/S, Assens 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.

K060539DPOAE20 , ECLIPSEK050496REM440K022728AUDIOTRAVELLER, MODEL AA222

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

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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