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FDA 510(k)

DPOAE20 , ECLIPSE

K-Number: K060539 · 2006-05-30

ApplicantInteracoustics A/S, Assens
Decision Date2006-05-30
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DPOAE20 , ECLIPSE 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 2006-05-30 under 510(k) number K060539. 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 DPOAE20 , ECLIPSE?

DPOAE20 , ECLIPSE is a medical device that received FDA 510(k) clearance on 2006-05-30. The listed applicant is Interacoustics A/S, Assens. The 510(k) number is K060539.

When did DPOAE20 , ECLIPSE receive FDA 510(k) clearance?

DPOAE20 , ECLIPSE received FDA 510(k) clearance on 2006-05-30, under 510(k) number K060539.

Who is the listed applicant for DPOAE20 , ECLIPSE?

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 DPOAE20 , ECLIPSE?

The FDA product code for DPOAE20 , ECLIPSE is EWO.

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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.

K050496REM440K030016TEOAE25K022728AUDIOTRAVELLER, 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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