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    K Number
    K150398
    Device Name
    EUM 100Pro
    Manufacturer
    OB TOOLS, LTD.
    Date Cleared
    2015-08-06

    (169 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    OB TOOLS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUM100Pro (Electro Uterine Monitor) is a transabdominal electromyography (EMG) monitor intended to non-invasively measure intrapartum uterine activity and fetal heart rate (FHR). The EUM100Pro acquires the signal from surface EMG electrodes placed on the patient abdomen. The EUM100Pro is intended for use on women (>36 completed weeks of gestation) in labor, with singleton pregnancies. The EUM100Pro is intended for use by healthcare professionals in a clinical setting.
    Device Description
    The EUM100Pro (electro uterine monitor) System is designed to present and transmit via RS232 protocol the electrical activity of the uterus and fetal heart rate. The data is shown and displayed as graphs (uterine activity and FHR) and similar to the commonly use toco-dynamometer / Doppler monitors. The EUM100Pro is built around an EN 60950 certified computer.
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