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FDA 510(k)

AUTOMATIC SCREENING AUDIOMETER

K-Number: K810537 · 1981-03-11

ApplicantPositron
Decision Date1981-03-11
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC SCREENING AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Positron. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810537. 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 AUTOMATIC SCREENING AUDIOMETER?

AUTOMATIC SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Positron. The 510(k) number is K810537.

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

AUTOMATIC SCREENING AUDIOMETER received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810537.

Who is the listed applicant for AUTOMATIC SCREENING AUDIOMETER?

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

What is the FDA product code for AUTOMATIC SCREENING AUDIOMETER?

The FDA product code for AUTOMATIC SCREENING AUDIOMETER is EWO.

Related Clinical Trials

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Other records listing Positron 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.

K926206POSICAM-HZ & POSICAM-HZLK911275POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEMK894998MODIFIED POSICAM SYSTEM MODEL 6.5

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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