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FDA 510(k)

AUDIOMETER MODEL-500

K-Number: K831431 · 1983-06-30

ApplicantAudimax
Decision Date1983-06-30
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOMETER MODEL-500 is the device name listed in this FDA 510(k) record. The listed applicant is Audimax. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831431. 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 AUDIOMETER MODEL-500?

AUDIOMETER MODEL-500 is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Audimax. The 510(k) number is K831431.

When did AUDIOMETER MODEL-500 receive FDA 510(k) clearance?

AUDIOMETER MODEL-500 received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831431.

Who is the listed applicant for AUDIOMETER MODEL-500?

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

What is the FDA product code for AUDIOMETER MODEL-500?

The FDA product code for AUDIOMETER MODEL-500 is EWO.

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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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