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510(k) Data Aggregation

    K Number
    K260585

    Validate with FDA (Live)

    Device Name
    Noxturnal Web
    Manufacturer
    Nox Medical Ehf
    Date Cleared
    2026-03-20

    (28 days)

    Product Code
    OLV
    Regulation Number
    882.1400
    Type
    Special
    Panel
    Neurology
    Age Range
    18 - 120
    Reference & Predicate Devices
    K201054,K241288
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Noxturnal Web is intended to be used for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults (18 years and above).

    Noxturnal Web is a software-only medical device to be used to analyze physiological signals and manually score sleep study results, including the staging of sleep, AHI, and detection of sleep disordered breathing events including obstructive apneas.

    It is intended to be used under the supervision of a clinician in a clinical environment.

    Device Description

    Noxturnal Web is a web-based software that can be utilized to screen various sleep and respiratory-related sleep disorders. The users of Noxturnal Web are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. Users can input a sleep study recording stored on the cloud (electronic medical record repository) using their established credentials. Once the sleep study data has been retrieved, the Noxturnal Web software can be used to display, manually analyze, generate reports and print the pre-recorded physiological signals.

    Noxturnal Web is used to read sleep study data for the display, analysis, summarization, and retrieval of physiological parameters recorded during sleep and awake. Noxturnal Web facilitates a user to review or manually score a sleep study either before the initiation of treatment or during the treatment follow-up for various sleep and respiratory-related sleep disorders.

    Noxturnal Web presents information from the input sleep study data in an organized layout. Multiple visualization layouts (e.g., Study Overview, Respiratory Signal Sheet, etc.) are available to allow the users to optimize the visualization of key data components. The reports generated by Noxturnal Web allow the inclusion of custom user comments, and these reports can then be viewed on the screen and/or printed.

    AI/ML Overview

    N/A

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