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510(k) Data Aggregation

    K Number
    K023195
    Device Name
    MAGLIFE C/MAGLIFE C PLUS
    Manufacturer
    SCHILLER MEDICAL S.A.
    Date Cleared
    2003-06-03

    (251 days)

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

    SCHILLER MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N₂O), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.
    Device Description
    The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO-), nitrous oxide concentration (%N2O), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking. The monitor consists of line-powered console (with optional back-up battery) which is placed outside the magnet boren, and appropriate electrodes, transducers, cables and tubes to allow the patient to be monitored during the examination. The console enclosure is a Faraday cage for the protection of sensitive electronic circuits.
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