BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247

    K Number: K061107 · Decision Aug 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    88
    Applicant Total
    9
    Review Days
    110

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    Basic Information

    Device Name
    DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
    K Number
    K061107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1600
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thermo Electron OY
    Date Received
    April 20, 2006
    Decision Date
    August 8, 2006
    Product Code
    CEM
    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
    CEM Electrode, Ion Specific, Potassium

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