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510(k) Data Aggregation

    K Number
    K964406
    Device Name
    AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
    Manufacturer
    Date Cleared
    1997-09-25

    (325 days)

    Product Code
    Regulation Number
    864.5950
    Why did this record match?
    Product Code :

    JWO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Daxor BVA-100 is a software package designed to calculate human blood volume, using the method of tracer dilution, utilizing tagged scrum albumin (a commonly used tag is I-131, resulting in "I-HSA"). Data inputs to the software come from the measured characteristics of patient blood samples (hematocrit and tracer concentration) and traccr calibration standards. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red ccll volumes, are reported, with statistics showing the quality of the results. The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.
    Device Description
    The Daxor BVA-100 is a software package designed to calculate human blood volume, using the method of tracer dilution, utilizing tagged scrum albumin (a commonly used tag is I-131, resulting in "I-HSA"). Data inputs to the software come from the measured characteristics of patient blood samples (hematocrit and tracer concentration) and traccr calibration standards. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red ccll volumes, are reported, with statistics showing the quality of the results. The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.
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