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FDA 510(k)

THE PILOT AUDIOMETER

K-Number: K951527 · 1995-05-03

ApplicantAmerican Electromedics Corp.
Decision Date1995-05-03
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

THE PILOT AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is American Electromedics Corp.. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K951527. 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 THE PILOT AUDIOMETER?

THE PILOT AUDIOMETER is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is American Electromedics Corp.. The 510(k) number is K951527.

When did THE PILOT AUDIOMETER receive FDA 510(k) clearance?

THE PILOT AUDIOMETER received FDA 510(k) clearance on 1995-05-03, under 510(k) number K951527.

Who is the listed applicant for THE PILOT AUDIOMETER?

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

What is the FDA product code for THE PILOT AUDIOMETER?

The FDA product code for THE PILOT AUDIOMETER is EWO.

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Other records listing American Electromedics 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.

K983049AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTERK983051AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERK983048AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERK983046AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTERK972221K 15 AUDIOMETERK970279RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)

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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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