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FDA 510(k)

HORTMANN AMDIS-OAE OAE ANALYZER

K-Number: K980505 · 1998-04-07

ApplicantHortmann AG
Decision Date1998-04-07
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HORTMANN AMDIS-OAE OAE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hortmann AG. It received FDA 510(k) clearance on 1998-04-07 under 510(k) number K980505. 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 HORTMANN AMDIS-OAE OAE ANALYZER?

HORTMANN AMDIS-OAE OAE ANALYZER is a medical device that received FDA 510(k) clearance on 1998-04-07. The listed applicant is Hortmann AG. The 510(k) number is K980505.

When did HORTMANN AMDIS-OAE OAE ANALYZER receive FDA 510(k) clearance?

HORTMANN AMDIS-OAE OAE ANALYZER received FDA 510(k) clearance on 1998-04-07, under 510(k) number K980505.

Who is the listed applicant for HORTMANN AMDIS-OAE OAE ANALYZER?

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

What is the FDA product code for HORTMANN AMDIS-OAE OAE ANALYZER?

The FDA product code for HORTMANN AMDIS-OAE OAE ANALYZER is EWO.

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Other records listing Hortmann AG 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.

K994033HORTMANN ECHOMASTER OAE ANALYZER

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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