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    K Number
    K121659
    Device Name
    BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
    Manufacturer
    ARCOS, INC.
    Date Cleared
    2013-04-18

    (317 days)

    Product Code
    PDT
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARCOS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Burn Resuscitation Decision Support System (BRDSS) is indicated for use in the care of adult patients with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for hourly fluid recommendations. The BRDSS is intended to be initiated within 24 hours of the burn incident and ending by 72 hours post burn.
    Device Description
    The BRDSS is a fluid calculator for use in the care of seriously burned patients. It is used to calculate the next dose of fluid for patients.
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