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

    MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER

    K Number: K002833 · Decision Sep 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    10
    Review Days
    16

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    Basic Information

    Device Name
    MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
    K Number
    K002833
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1360
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Standard Imaging, Inc.
    Date Received
    September 12, 2000
    Decision Date
    September 28, 2000
    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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