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FDA 510(k)

K 15 AUDIOMETER

K-Number: K972221 · 1997-09-08

ApplicantAmerican Electromedics Corp.
Decision Date1997-09-08
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

K 15 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 1997-09-08 under 510(k) number K972221. 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 K 15 AUDIOMETER?

K 15 AUDIOMETER is a medical device that received FDA 510(k) clearance on 1997-09-08. The listed applicant is American Electromedics Corp.. The 510(k) number is K972221.

When did K 15 AUDIOMETER receive FDA 510(k) clearance?

K 15 AUDIOMETER received FDA 510(k) clearance on 1997-09-08, under 510(k) number K972221.

Who is the listed applicant for K 15 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 K 15 AUDIOMETER?

The FDA product code for K 15 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 PRINTERK970279RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)K955289RACE CAR TYMPANOMETER

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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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