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FDA 510(k)

HEARID WIDEBAND MIDDLE EAR POWER ANALYZER

K-Number: K053216 · 2006-02-10

ApplicantMimosa Acoustics, Inc.
Decision Date2006-02-10
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARID WIDEBAND MIDDLE EAR POWER 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 2006-02-10 under 510(k) number K053216. 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 WIDEBAND MIDDLE EAR POWER ANALYZER?

HEARID WIDEBAND MIDDLE EAR POWER ANALYZER is a medical device that received FDA 510(k) clearance on 2006-02-10. The listed applicant is Mimosa Acoustics, Inc.. The 510(k) number is K053216.

When did HEARID WIDEBAND MIDDLE EAR POWER ANALYZER receive FDA 510(k) clearance?

HEARID WIDEBAND MIDDLE EAR POWER ANALYZER received FDA 510(k) clearance on 2006-02-10, under 510(k) number K053216.

Who is the listed applicant for HEARID WIDEBAND MIDDLE EAR POWER 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 WIDEBAND MIDDLE EAR POWER ANALYZER?

The FDA product code for HEARID WIDEBAND MIDDLE EAR POWER ANALYZER is EWO.

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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 SYSTEMK063338HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS 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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