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FDA 510(k)

OTODYNAMICS OTOPORT

K-Number: K072033 · 2007-11-13

ApplicantOtodynamics, Ltd.
Decision Date2007-11-13
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTODYNAMICS OTOPORT is the device name listed in this FDA 510(k) record. The listed applicant is Otodynamics, Ltd.. It received FDA 510(k) clearance on 2007-11-13 under 510(k) number K072033. 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 OTODYNAMICS OTOPORT?

OTODYNAMICS OTOPORT is a medical device that received FDA 510(k) clearance on 2007-11-13. The listed applicant is Otodynamics, Ltd.. The 510(k) number is K072033.

When did OTODYNAMICS OTOPORT receive FDA 510(k) clearance?

OTODYNAMICS OTOPORT received FDA 510(k) clearance on 2007-11-13, under 510(k) number K072033.

Who is the listed applicant for OTODYNAMICS OTOPORT?

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

What is the FDA product code for OTODYNAMICS OTOPORT?

The FDA product code for OTODYNAMICS OTOPORT is EWO.

Related Clinical Trials

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.

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Other records listing Otodynamics, Ltd. 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.

K240430Otoport ProK983350ILO292 DP ECHOPORT PLUS OAE SYSTEMK983351ILO292 DP ECHOPORT PLUS OAE SYSTEMK983352ILO2088 ENCHOCHECK OR ILO2088 OTOCHECKK962995ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC

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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