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510(k) Data Aggregation

    K Number
    K103631
    Device Name
    SLEEPMINDER BREATHING FREQUENCY INDICATOR
    Manufacturer
    BIANCAMED LIMITED
    Date Cleared
    2011-07-21

    (220 days)

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

    BIANCAMED LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used for the spot measurement of respiration rate of an adult patient in a hospital and clinical setting. It is not a vital signs monitor or an apnea monitor. The device is indicated for use as suitable for use on adult patients. It should not be used on patients that exhibit uncontrolled limb movement.
    Device Description
    The SleepMinder Breathing Frequency Indicator BM07 consists of - A small sensor unit that can stand on a desk top or shelf. The sensor . unit emits a very low power radio signal that is aimed at the patient. The sensor utilizes the reflected radio signal to measure the chest movement of the patient, and thus discern the respiration rate. The sensor has no part that is in contact with the patient. - The sensor data is transmitted to a PC running a proprietary display . program. The validated transmission method to the PC is a BlueTooth wireless link. - . The PC display program runs a proprietary algorithm to extract the respiration rate from the sensor movement data. The program displays - The respiration rate, and o - Indicates whether there is a valid target, whether the o target is moving too much for a breathing signal to be indentified or the signal is clear enough for a breathing rate to be calculated.
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