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510(k) Data Aggregation

    K Number
    K153079
    Device Name
    Axeo 3 Patient Monitor
    Date Cleared
    2016-03-17

    (146 days)

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

    AXEO MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The purpose and function of the AXEO 3 patient monitor basic physiological parameters including - · ECG waveform derived from 3 or 5 lead measurements - · Heart Rate - · NIBP (systolic, diastolic, and mean arterial pressure) - · SpO2 - · Respiration - · Temperature up to 2 channels (Dual Temperature) The target population is for adult, neonate and pediatric patients. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner. This device is not intended for use as an apnea monitor. Prescription Use: Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The Axeo 3 Patient Monitor is a comprehensive monitoring system with up to 8 traces compiling, processing, and displaying data from up to six different parameters: ECG. Heart Rate. NIBP. SoO2. Respiration, and Temperature. It integrates parameter measuring modules, a display, and a recorder in one device, featuring compactness, light weight, and portability. A built-in rechargeable battery facilitates off-AC-power transport of the patient providing at monitoring from a fully charged battery. The battery recharges when AC power is reconnected to the monitor. The associated accessories include: - ECG Cable - . SpO2 Finger Probes - . Blood Pressure Cuffs - Temperature Probe ● - . Power Supply with Power Cord - . User's Manual
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