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FDA 510(k)

GN OTOMETRICS INSERT EARPHONES

K-Number: K081234 · 2008-07-14

ApplicantGn Otometrics
Decision Date2008-07-14
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GN OTOMETRICS INSERT EARPHONES is the device name listed in this FDA 510(k) record. The listed applicant is Gn Otometrics. It received FDA 510(k) clearance on 2008-07-14 under 510(k) number K081234. 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 GN OTOMETRICS INSERT EARPHONES?

GN OTOMETRICS INSERT EARPHONES is a medical device that received FDA 510(k) clearance on 2008-07-14. The listed applicant is Gn Otometrics. The 510(k) number is K081234.

When did GN OTOMETRICS INSERT EARPHONES receive FDA 510(k) clearance?

GN OTOMETRICS INSERT EARPHONES received FDA 510(k) clearance on 2008-07-14, under 510(k) number K081234.

Who is the listed applicant for GN OTOMETRICS INSERT EARPHONES?

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

What is the FDA product code for GN OTOMETRICS INSERT EARPHONES?

The FDA product code for GN OTOMETRICS INSERT EARPHONES 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 Gn Otometrics 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.

K161707Madsen ZodiacK122550ICS IMPULSEK122028AURICAL HITK122067TYPE 1077 ACCUSCREENK092373ICS CHARTR EP 200

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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