Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K223922
    Device Name
    SOMNUM (V.1.1.2.)
    Manufacturer
    Honeynaps Co., Ltd
    Date Cleared
    2023-08-16

    (229 days)

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

    Honeynaps Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SOMNUM is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. SOMNUM is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay(retrieve), summarize and reports generation of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients. For respiratory events - Sleep Disordered Breathing (Apneas)- obstructive, central, mixed apneas, and hypopneas must be manually scored by physician. The device does not output specific apnea or hypopnea events and therefore should not be used for management decisions.
    Device Description
    SOMNUM is a standalone software application that analyze previously recorded physiological data obtained during level 1 sleep studies, referred to as polysomnography (PSG) records. The SOMNUM software can analyze any EDF files. Automated algorithms are applied to the raw signals in order to identify the occurrence of certain events. The software automates recognition of: - · Sleep Stage Events : Wake, Stage N1, Stage N2, Stage N3, Stage REM - Respiratory Events : Sleep Disordered Breathing (device output does not distinguish between Apneas and Hypopneas. Obstructive, central, mixed apneas, and hypopneas must be manually scored by physician) - · Arousal Events - · Leg Movement Events : Periodic Leg Movements during Sleep (PLMs) The SOMNUM software can be used as a stand-alone application for use on Windows 10 operating system platform. All processing, scoring, and analysis of signal data occurs on local desktop PC.
    Ask a Question

    Page 1 of 1