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510(k) Data Aggregation

    K Number
    K133973
    Device Name
    TEMPUS PRO WITH ENHANCED FEATURES
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD
    Date Cleared
    2014-08-14

    (231 days)

    Product Code
    QYW, MHX
    Regulation Number
    870.1025
    Why did this record match?
    Product Code :

    QYW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for: 3 & 5 Lead ECG monitoring; 12 Lead ECG recording; real-time arrhythmia detection / alarming; QT measurement / alarming and ST measurements / alarming: impedance pneumography: noninvasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure. The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). The device is indicated for adults, paediatrics and neonates.
    Device Description
    The Tempus Pro is a multi-parameter vital signs monitor designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3&5 lead ECG monitoring, 12 lead ECG recording, real-time arrhythmia detection / alarming, QT measurement / alarming and ST measurements / alarming pulse oximetry, non-invasive blood pressure, sidestream capnometry, 2 channels of contact temperature, impedance respiration, up to 4 channels of invasive pressure and user configurable alarms. In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a software system (called i2i) expected to be based in a facility far from the user e.g. a response centre facility. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.
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