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FDA 510(k)

ERO SCAN OAE TEST SYSTEM

K-Number: K010165 · 2001-03-12

ApplicantEtymotic Research
Decision Date2001-03-12
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ERO SCAN OAE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Etymotic Research. It received FDA 510(k) clearance on 2001-03-12 under 510(k) number K010165. 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 ERO SCAN OAE TEST SYSTEM?

ERO SCAN OAE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-12. The listed applicant is Etymotic Research. The 510(k) number is K010165.

When did ERO SCAN OAE TEST SYSTEM receive FDA 510(k) clearance?

ERO SCAN OAE TEST SYSTEM received FDA 510(k) clearance on 2001-03-12, under 510(k) number K010165.

Who is the listed applicant for ERO SCAN OAE TEST SYSTEM?

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 ERO SCAN OAE TEST SYSTEM?

The FDA product code for ERO SCAN OAE TEST SYSTEM 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 PROBEK980533ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)K930553CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENTK930003TUBEPHONE 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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