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510(k) Data Aggregation

    K Number
    K011741
    Device Name
    CRIT-LINE MONITOR III TQA (CLM TQA)
    Manufacturer
    HEMAMETRICS
    Date Cleared
    2002-07-23

    (413 days)

    Product Code
    FIL
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAMETRICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the CRIT-LINE III TQA Monitor is as a non-invasive hematocrit, oxygen saturation, and percent change in blood volume monitor. The CRIT-LINE III TQA Monitor also non-invasively estimates access recirculation and non-invasively estimates access blood flow. In addition, the CLM III TQA Monitor calculates an estimated Urea Reduction Ratio based on relative changes in urea nitrogen concentration in the spent dialysate.
    Device Description
    The CRIT-LINE III TQA is an FDA cleared device that non-invasively measures Hct, O2 Sat, Percent Change in Blood Volume. The CLM III TOA also estimates Access Recirculation and Access Blood Flow. The URR sensor is an additional attachment to the CRIT-LINE III TOA. The optical light emitted by the URR sensor is directed through the spent dialysate stream and absorbed by the constituents of the spent dialysate. The transmitted light is then detected and the relative urea nitrogen concentration in the spent dialysate is calculated.
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