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FDA 510(k)

INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)

K-Number: K900096 · 1990-05-31

ApplicantArtifical Hearing Systems Corp.
Decision Date1990-05-31
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) is the device name listed in this FDA 510(k) record. The listed applicant is Artifical Hearing Systems Corp.. It received FDA 510(k) clearance on 1990-05-31 under 510(k) number K900096. 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 INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)?

INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) is a medical device that received FDA 510(k) clearance on 1990-05-31. The listed applicant is Artifical Hearing Systems Corp.. The 510(k) number is K900096.

When did INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) receive FDA 510(k) clearance?

INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) received FDA 510(k) clearance on 1990-05-31, under 510(k) number K900096.

Who is the listed applicant for INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)?

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

What is the FDA product code for INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)?

The FDA product code for INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) 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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