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510(k) Data Aggregation

    K Number
    K202464
    Device Name
    Vital Sign Monitoring Sensor (Model :XK300)
    Manufacturer
    Xandar Kardian Inc.
    Date Cleared
    2021-04-26

    (242 days)

    Product Code
    DRT
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xandar Kardian Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vital Sign Monitoring Sensor (Model XK300) is intended to measure heart rate and respiration rate in adult patients in a general care hospital environment including nursing homes. The Vital Sign Monitoring Sensor can be used for home healthcare for data collection to inform patient care but not to acutely treat a patient. XK300 monitors presence or absence of a patient in detection area of within 7 meters. The XK30 also monitors the length of continuous patient motion or absence of patient motion.
    Device Description
    The Vital Sign Monitoring Sensor (Model XK300) measures heart rate, respiratory rate (breathing rate), and movement of people with very little or no movement (rest mode) using Impulse Radio Ultra-Wideband (IR UWB) radar technology. The heart rate and respiratory rate are measured by detecting minute displacements of the chest and converting the movement into the number of breaths and heart beats per minute.
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