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FDA 510(k)

CUB DIS II DPOAE MEASUREMENT SYSTEM

K-Number: K981460 · 1998-05-20

ApplicantMimosa Acoustics, Inc.
Decision Date1998-05-20
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUB DIS II DPOAE MEASUREMENT SYSTEM 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 1998-05-20 under 510(k) number K981460. 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 II DPOAE MEASUREMENT SYSTEM?

CUB DIS II DPOAE MEASUREMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Mimosa Acoustics, Inc.. The 510(k) number is K981460.

When did CUB DIS II DPOAE MEASUREMENT SYSTEM receive FDA 510(k) clearance?

CUB DIS II DPOAE MEASUREMENT SYSTEM received FDA 510(k) clearance on 1998-05-20, under 510(k) number K981460.

Who is the listed applicant for CUB DIS II DPOAE MEASUREMENT SYSTEM?

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 CUB DIS II DPOAE MEASUREMENT SYSTEM?

The FDA product code for CUB DIS II DPOAE MEASUREMENT SYSTEM 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 ANALYZERK053216HEARID WIDEBAND MIDDLE EAR POWER ANALYZER

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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