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FDA 510(k)

GSI AUDERA

K-Number: K011135 · 2001-07-26

ApplicantNicolet Biomedical
Decision Date2001-07-26
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GSI AUDERA is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical. It received FDA 510(k) clearance on 2001-07-26 under 510(k) number K011135. 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 GSI AUDERA?

GSI AUDERA is a medical device that received FDA 510(k) clearance on 2001-07-26. The listed applicant is Nicolet Biomedical. The 510(k) number is K011135.

When did GSI AUDERA receive FDA 510(k) clearance?

GSI AUDERA received FDA 510(k) clearance on 2001-07-26, under 510(k) number K011135.

Who is the listed applicant for GSI AUDERA?

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

What is the FDA product code for GSI AUDERA?

The FDA product code for GSI AUDERA is EWO.

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Other records listing Nicolet Biomedical 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.

K020754NICOLET PIONEER TC8080K013281VERSALAB APMK013419NICOLET ELECTROMAGNETIC NAVIGATION SYSTEMK010521NICOLET VERSALABK002766NICOLET VASOGUARDK993939NICOLET EME LEGEND TC22

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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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