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FDA 510(k)

CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT

K-Number: K930553 · 1993-09-29

ApplicantEtymotic Research
Decision Date1993-09-29
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Etymotic Research. It received FDA 510(k) clearance on 1993-09-29 under 510(k) number K930553. 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 CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT?

CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT is a medical device that received FDA 510(k) clearance on 1993-09-29. The listed applicant is Etymotic Research. The 510(k) number is K930553.

When did CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT receive FDA 510(k) clearance?

CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT received FDA 510(k) clearance on 1993-09-29, under 510(k) number K930553.

Who is the listed applicant for CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT?

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

What is the FDA product code for CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT?

The FDA product code for CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT is EWO.

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Other records listing Etymotic Research 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.

K011114ETYMOTIC RESEARCH ER-10D OAE PROBEK010165ERO SCAN OAE TEST SYSTEMK980533ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)K930003TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONESK873298ELEC-TIPK861113ER-7C CLINICAL PROBE MICROPHONE

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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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