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510(k) Data Aggregation

    K Number
    K241960
    Device Name
    DeepRESP
    Manufacturer
    Nox Medical ehf
    Date Cleared
    2025-03-14

    (254 days)

    Product Code
    OLZ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nox Medical ehf

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, patient home, or an ambulatory setting. It is indicated for use with adults (22 years and above) in a clinical environment by or on the order of a medical professional. DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotation of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional.
    Device Description
    DeepRESP is a cloud-based software as a medical device (SaMD), designed to perform analysis of sleep study recordings, with and without EEG signals, providing data for the assessment and diagnosis of sleep-related disorders. Its algorithmic framework provides the derivation of sleep staging including arousals, scoring of respiratory events and key parameters such as the Apnea-Hypopnea Index (AHI). DeepRESP is hosted on a serverless stack. It consists of: - A web Application Programming Interface (API) intended to interface with a third-party client application, allowing medical professionals to access DeepRESP's analytical capabilities. - Predefined sequences called Protocols that run data analyses, including artificial intelligence and rule-based models for the scoring of sleep studies, and a parameter calculation service. - A Result storage using an object storage service to temporarily store outputs from the DeepRESP Protocols.
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    K Number
    K241288
    Device Name
    Noxturnal Web
    Manufacturer
    Nox Medical ehf
    Date Cleared
    2024-12-23

    (230 days)

    Product Code
    OLV, 510
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nox Medical ehf

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 only. 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 respiratoryrelated 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 prerecorded 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.
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    K Number
    K151361
    Device Name
    Nox RIP Belts & Cables
    Manufacturer
    NOX MEDICAL ehf
    Date Cleared
    2015-11-06

    (169 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOX MEDICAL ehf

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nox RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. The Nox RIP Belts are indicated for use on patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient 's home. The RIP Belt Cables are intended to interconnect Nox RIP belts (respiratory effort sensors) and Nox sleep devices, to allow measuring of respiratory effort signals. The RIP Belt Cables are indicated for use on patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home. The Third Party RIP Belt Cables are intended to allow measuring of respiratory effort signals by interconnecting Nox RIP belts (respiratory effort sensors) and sleep devices with oscillation circuitry capable of measuring inductance between 1 and 5 µH. The Third Party RIP Belt Cables are indicated for use on patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home.
    Device Description
    The Nox RIP Belts are respiratory effort sensors that are intended to function as an accessory with sleep/polysomnography (PSG) systems. The RIP Belts measure respiratory effort signals based on Respiratory Inductance Plethysmography (RIP) technology, which is the gold standard technology for respiratory effort belts. Two RIP belts are used to measure the respiratory effort of the patient. One belt is placed around the patient's abdomen and the other around the patient's thorax. Both abdomen and thorax belts are identical. The Nox RIP Belt Cables are used to connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system. There are two product groups for the Nox RIP Belt Cables; RIP Belt Cables and Third Party RIP Belt Cables. The RIP Belt Cables are designed for use with Nox recorders only. Those are abdomen cables only because the thorax belt is attached directly to the Nox recorders. The Third Party RIP Belt Cables are designed for use with third party recorders. The Third Party RIP Belt Cables come in pairs for abdomen and thorax.
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