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

    LUDLUM 88 DOSE CALIBRATOR

    K Number: K842570 · Decision Aug 7, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    LUDLUM 88 DOSE CALIBRATOR
    K Number
    K842570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1360
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Ludlum Measurements, Inc.
    Date Received
    July 3, 1984
    Decision Date
    August 7, 1984
    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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