BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240

    K Number: K040958 · Decision Feb 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    1
    Review Days
    308

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    Basic Information

    Device Name
    PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
    K Number
    K040958
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tokyo Boeki Medical System , Ltd.
    Date Received
    April 13, 2004
    Decision Date
    February 15, 2005
    Product Code
    JJE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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