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510(k) Data Aggregation

    K Number
    K992255
    Device Name
    CKHEMO, MODEL CKHEMO VERSION 1.0
    Manufacturer
    CSAM, INC.
    Date Cleared
    1999-11-30

    (147 days)

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

    CSAM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate total urea clearance (Kt/V), total urea clearance (Kt/V) delivered using the natural log formula, residual renal urea clearance (KrU), normalized protein catabolic rate (NPCR), actual blood flow, urea reduction ratio, body water volume calculated by urea kinetic modeling, total body water volume calculated using Watson's formula, actual weight loss after treatment, percent deviation (%Dev), and treatment time. These values are calculated using the test results of blood drawn immediately prior to and upon completion of kidney hemodialysis treatment based on the existing scientific formulas for single pool urea kinetic modeling. The device software is not meant to serve as the sole tool for determining effectiveness of treatment but as an adjunct to assist the physician in making the determination.
    Device Description
    The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate various parameters related to kidney hemodialysis treatment based on test results of blood drawn before and after treatment and existing scientific formulas for single pool urea kinetic modeling.
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