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510(k) Data Aggregation

    K Number
    K040188
    Device Name
    INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
    Manufacturer
    Draeger Medical Systems, Inc.
    Date Cleared
    2004-04-14

    (77 days)

    Product Code
    NHP
    Regulation Number
    868.1500
    Why did this record match?
    Product Code :

    NHP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is capable of monitoring: Heart Rate, Respiration Rate, Invasive Pressure, Non-Invasive Pressure, Arrhythmia, Temperature, Arterial oxygen saturation, Pulse rate, central apnea accomplished through impedance plethysmography, apnea accomplished through capnograpy, end-tidal CO2, ST Segment Analysis. This Infinity GammaXL and SC 6802XL will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network. When connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
    Device Description
    The INFINITY GammaXL and SC 6802XL with software version VF3 and above are capable of displaying gas-monitoring data received from a Scio gas module (K031340). Anesthetic gas monitoring is available when a GammaXL or SC 6802XL is attacted via a specific cable to a Scio gas module. This is a password protected locked optical. The GammaXL and SC 6802XL with Scio are similar to the Infinity Modular Monitors with Scio (K031340) in that they display gas-monitoring parameters received from the Scio gas module.
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