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FDA 510(k)

ACOUSTIC APPRAISE CD-3

K-Number: K923013 · 1992-08-14

ApplicantQualitone
Decision Date1992-08-14
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACOUSTIC APPRAISE CD-3 is the device name listed in this FDA 510(k) record. The listed applicant is Qualitone. It received FDA 510(k) clearance on 1992-08-14 under 510(k) number K923013. 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 ACOUSTIC APPRAISE CD-3?

ACOUSTIC APPRAISE CD-3 is a medical device that received FDA 510(k) clearance on 1992-08-14. The listed applicant is Qualitone. The 510(k) number is K923013.

When did ACOUSTIC APPRAISE CD-3 receive FDA 510(k) clearance?

ACOUSTIC APPRAISE CD-3 received FDA 510(k) clearance on 1992-08-14, under 510(k) number K923013.

Who is the listed applicant for ACOUSTIC APPRAISE CD-3?

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

What is the FDA product code for ACOUSTIC APPRAISE CD-3?

The FDA product code for ACOUSTIC APPRAISE CD-3 is EWO.

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Other records listing Qualitone 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.

K961827IN-THE-EARK955466DYNAMEQ-II OPTIONK955359CYBER III OPTION UM, UC312, UC10, UCICK953884PROPHETK935348ODYSSEY CLINICAL AUDIOMETERK935289PRO FIT-CYBER II OPTION

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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

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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