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FDA 510(k)

NOX T3, NOXTURNAL (PC APPLICATION)

K-Number: K082113 · 2008-11-07

ApplicantNox Medical
Decision Date2008-11-07
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NOX T3, NOXTURNAL (PC APPLICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Nox Medical. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K082113. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOX T3, NOXTURNAL (PC APPLICATION)?

NOX T3, NOXTURNAL (PC APPLICATION) is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Nox Medical. The 510(k) number is K082113.

When did NOX T3, NOXTURNAL (PC APPLICATION) receive FDA 510(k) clearance?

NOX T3, NOXTURNAL (PC APPLICATION) received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082113.

Who is the listed applicant for NOX T3, NOXTURNAL (PC APPLICATION)?

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

What is the FDA product code for NOX T3, NOXTURNAL (PC APPLICATION)?

The FDA product code for NOX T3, NOXTURNAL (PC APPLICATION) is MNR.

Related Clinical Trials

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Other records listing Nox Medical 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.

K192469Nox Sleep SystemK124062QDC-PRO, AND NOX-RIP

Related Devices (Code: MNR)

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.

K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHK254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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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