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    K Number
    K200337
    Device Name
    FloPatch (FP120)
    Manufacturer
    Flosonics Medical (r/a 1929803 Ontario Corp.)
    Date Cleared
    2020-03-24

    (42 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flosonics Medical (r/a 1929803 Ontario Corp.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode. The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.
    Device Description
    The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic transducer to a peripheral vessel such as the carotid artery. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.
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    K Number
    K191388
    Device Name
    FloPatch (FP110)
    Manufacturer
    Flosonics Medical (r/a 1929803 Ontario Corp.)
    Date Cleared
    2019-06-21

    (28 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flosonics Medical (r/a 1929803 Ontario Corp.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FloPatch(FP110) is intended for the detection of blood flow in peripheral vasculature. The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use only.
    Device Description
    The FloPatch (FP110) is a non-invasive blood flow detection device intended to be used in a medical/hospital setting for use by medical professionals. The device uses ultrasound and the Doppler effect to evaluate the flow of blood. The device consists of signal processing box (main unit) and an ultrasonic vascular flow transducer. The device transmits ultrasonic waves from the vascular flow transducer to a peripheral vessel such as the carotid artery. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing box (main unit) which outputs the doppler signal to the device speaker.
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