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FDA 510(k)

AUDIO EXPERT AUDIOMETER

K-Number: K942716 · 1994-09-02

ApplicantBeltone Electronics Corp.
Decision Date1994-09-02
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIO EXPERT AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Beltone Electronics Corp.. It received FDA 510(k) clearance on 1994-09-02 under 510(k) number K942716. 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 AUDIO EXPERT AUDIOMETER?

AUDIO EXPERT AUDIOMETER is a medical device that received FDA 510(k) clearance on 1994-09-02. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K942716.

When did AUDIO EXPERT AUDIOMETER receive FDA 510(k) clearance?

AUDIO EXPERT AUDIOMETER received FDA 510(k) clearance on 1994-09-02, under 510(k) number K942716.

Who is the listed applicant for AUDIO EXPERT AUDIOMETER?

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

What is the FDA product code for AUDIO EXPERT AUDIOMETER?

The FDA product code for AUDIO EXPERT AUDIOMETER is EWO.

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Other records listing Beltone Electronics Corp. as applicant

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K971852AIR CONDUCTION HAEARING AIDSK963958IMPRESS, PERFECTA, ACU-FORM, AND ACUFITK955930BELTONE COMPOSER 2000 BTE HPK954936BELTONE ULTIMA 80 OTOSONIC POWER PASK943616BELTONE PERSONAL HEARING SCREENERK951587BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K

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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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