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510(k) Data Aggregation

    K Number
    K965079
    Device Name
    SOMNITOR 32K SLEEP ACTIVITY MONITOR
    Date Cleared
    1997-07-10

    (203 days)

    Product Code
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURIM PHARMACEUTICALS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Somnitor 32K Activity Monitor is intended to monitor physical activity with an ambulatory monitoring and data logging device and after downloading the data to a personal computer, determine the periods when the patient was awake or sleeping using a validated algorithm.
    Device Description
    The Somnitor 32K Activity Monitor is a wrist worn device consisting of an activity (movement) detector and a data logger with internal data storage. The device is used with a personal computer running software which can download data from the data logger and analyze it according to a validated algorithm to determine periods of sleep and wakefulness. Four algorithms for assessing sleep activity data may be used for analysis, including the Bounded Trigger algorithm, the Cole algorithm, the Sadeh algorithm, and a new Neurim algorithm.
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