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510(k) Data Aggregation

    K Number
    K040958
    Device Name
    PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
    Manufacturer
    TOKYO BOEKI MEDICAL SYSTEM LTD.
    Date Cleared
    2005-02-15

    (308 days)

    Product Code
    JJE, CEM, CGZ, JGS, JIX
    Regulation Number
    862.2160
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKYO BOEKI MEDICAL SYSTEM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.
    Device Description
    The Prestige 24i with Ion Selective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in samples, using indirect potentiometry.
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