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FDA 510(k)

AUDIOTESTER SCREENING AUDIOMETER

K-Number: K894484 · 1990-06-26

ApplicantPrometex, Inc.
Decision Date1990-06-26
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOTESTER SCREENING AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Prometex, Inc.. It received FDA 510(k) clearance on 1990-06-26 under 510(k) number K894484. 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 AUDIOTESTER SCREENING AUDIOMETER?

AUDIOTESTER SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1990-06-26. The listed applicant is Prometex, Inc.. The 510(k) number is K894484.

When did AUDIOTESTER SCREENING AUDIOMETER receive FDA 510(k) clearance?

AUDIOTESTER SCREENING AUDIOMETER received FDA 510(k) clearance on 1990-06-26, under 510(k) number K894484.

Who is the listed applicant for AUDIOTESTER SCREENING AUDIOMETER?

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

What is the FDA product code for AUDIOTESTER SCREENING AUDIOMETER?

The FDA product code for AUDIOTESTER SCREENING AUDIOMETER is EWO.

Related Clinical Trials

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.

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Other records listing Prometex, Inc. 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.

K900068ARISTEE (RESIN, CROWN AND BRIDGES)K892710ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)K872894A2J MZ 44 LASER LIGHT FOR POSITIONING

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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