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FDA 510(k)

ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK

K-Number: K983352 · 1998-12-11

ApplicantOtodynamics, Ltd.
Decision Date1998-12-11
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Otodynamics, Ltd.. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K983352. 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 ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK?

ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Otodynamics, Ltd.. The 510(k) number is K983352.

When did ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK receive FDA 510(k) clearance?

ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK received FDA 510(k) clearance on 1998-12-11, under 510(k) number K983352.

Who is the listed applicant for ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK?

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 ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK?

The FDA product code for ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK 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 ProK072033OTODYNAMICS OTOPORTK983350ILO292 DP ECHOPORT PLUS OAE SYSTEMK983351ILO292 DP ECHOPORT PLUS OAE SYSTEMK962995ILO88. 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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