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FDA 510(k)

SOUND SELECTOR FULL-SERVICE AUDIOMETER

K-Number: K933097 · 1994-01-24

ApplicantEnsoniq Corp.
Decision Date1994-01-24
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SOUND SELECTOR FULL-SERVICE AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Ensoniq Corp.. It received FDA 510(k) clearance on 1994-01-24 under 510(k) number K933097. 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 SOUND SELECTOR FULL-SERVICE AUDIOMETER?

SOUND SELECTOR FULL-SERVICE AUDIOMETER is a medical device that received FDA 510(k) clearance on 1994-01-24. The listed applicant is Ensoniq Corp.. The 510(k) number is K933097.

When did SOUND SELECTOR FULL-SERVICE AUDIOMETER receive FDA 510(k) clearance?

SOUND SELECTOR FULL-SERVICE AUDIOMETER received FDA 510(k) clearance on 1994-01-24, under 510(k) number K933097.

Who is the listed applicant for SOUND SELECTOR FULL-SERVICE AUDIOMETER?

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

What is the FDA product code for SOUND SELECTOR FULL-SERVICE AUDIOMETER?

The FDA product code for SOUND SELECTOR FULL-SERVICE AUDIOMETER is EWO.

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Other records listing Ensoniq Corp. 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.

K882633ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID

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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