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510(k) Data Aggregation

    K Number
    K250851

    Validate with FDA (Live)

    Date Cleared
    2025-12-14

    (268 days)

    Product Code
    Regulation Number
    882.1400
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K210034

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cadwell Hypnos is a software application used for Polysomnography (PSG) and other clinical sleep studies. It is intended for use by research and clinical sleep professionals. It measures, records, displays, organizes, analyzes, summarizes, and retrieves physiological signals during sleep and wake used to assist in the assessment of sleep and the diagnosis of various sleep disorders including sleep related breathing disorders. The software can be used for analysis (computer-assisted as well as manual scoring of events), display, retrieval, summarization, reporting and networking of data received from devices used to monitor sleep related parameters.

    Hypnos is indicated for use in all sleep disorders patient populations from neonate to adult, including infants, pediatrics and geriatric populations. Computer-assisted analysis features of the application are only intended for use on adults.

    Hypnos is only indicated for use by trained medical professionals for the purpose of assessing sleep disorders.

    Intended environments include hospitals, institutions, sleep centers, sleep clinics, and other sleep disorders testing environments.

    Hypnos is NOT intended to be used to perform automatic diagnosis.

    Device Description

    Hypnos software is used to acquire, record, transmit, analyze, store, manage, report, and display physiological and environmental data collected by PSG and/or HSAT hardware. Hypnos software allows users to analyze signals both manually and using detectors to facilitate interpretation of a sleep study by a qualified user.

    AI/ML Overview

    N/A

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