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FDA 510(k)

HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER

K-Number: K063338 · 2007-01-04

ApplicantMimosa Acoustics, Inc.
Decision Date2007-01-04
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Mimosa Acoustics, Inc.. It received FDA 510(k) clearance on 2007-01-04 under 510(k) number K063338. 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 HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER?

HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER is a medical device that received FDA 510(k) clearance on 2007-01-04. The listed applicant is Mimosa Acoustics, Inc.. The 510(k) number is K063338.

When did HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER receive FDA 510(k) clearance?

HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER received FDA 510(k) clearance on 2007-01-04, under 510(k) number K063338.

Who is the listed applicant for HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER?

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

What is the FDA product code for HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER?

The FDA product code for HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER is EWO.

Related Clinical Trials

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Other records listing Mimosa Acoustics, Inc. 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.

K123624OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEMK053216HEARID WIDEBAND MIDDLE EAR POWER ANALYZERK981460CUB DIS II DPOAE MEASUREMENT SYSTEM

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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