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510(k) Data Aggregation

    K Number
    K121573
    Device Name
    INTEGRA CAMINO ICP MONITOR
    Manufacturer
    INTRGRA LIFESCIENCES CORPORATION
    Date Cleared
    2012-09-10

    (104 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRGRA LIFESCIENCES CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integra Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.
    Device Description
    The Integra® Camino® ICP Monitor is a compact, portable device that provides tools for continuously determining and monitoring intracranial pressure (ICP) and intracranial temperature (ICT) directly in the brain, depending on which catheters are connected to the system. This monitor supports Integra fiberoptic and strain gauge catheters. The Integra Camino ICP Monitor displays both ICP and temperature in numeric format. The device also displays real-time ICP waveform data. It will store the mean ICP trend data from the most recent 5 days. The user can elect to extract the ICP trend data stored on the Monitor to an external memory device or stream the data to a compatible PC via the USB output. The device also provides analog output for display on compatible bedside monitors.
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