BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RADIOISOTOPE CALIBRATOR MODEL 34-062

    K Number: K850815 · Decision Aug 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    40
    Review Days
    174

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    Basic Information

    Device Name
    RADIOISOTOPE CALIBRATOR MODEL 34-062
    K Number
    K850815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1360
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Victoreen, Inc.
    Date Received
    February 28, 1985
    Decision Date
    August 21, 1985
    Product Code
    KPT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPT Calibrator, Dose, Radionuclide

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