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FDA 510(k)

QDC-PRO, AND NOX-RIP

K-Number: K124062 · 2013-07-10

ApplicantNox Medical
Decision Date2013-07-10
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

QDC-PRO, AND NOX-RIP is the device name listed in this FDA 510(k) record. The listed applicant is Nox Medical. It received FDA 510(k) clearance on 2013-07-10 under 510(k) number K124062. 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 QDC-PRO, AND NOX-RIP?

QDC-PRO, AND NOX-RIP is a medical device that received FDA 510(k) clearance on 2013-07-10. The listed applicant is Nox Medical. The 510(k) number is K124062.

When did QDC-PRO, AND NOX-RIP receive FDA 510(k) clearance?

QDC-PRO, AND NOX-RIP received FDA 510(k) clearance on 2013-07-10, under 510(k) number K124062.

Who is the listed applicant for QDC-PRO, AND NOX-RIP?

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 QDC-PRO, AND NOX-RIP?

The FDA product code for QDC-PRO, AND NOX-RIP is MNR.

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 SystemK082113NOX T3, NOXTURNAL (PC APPLICATION)

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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