BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SELECTRON LDR SELECTRON LOW DOSE RATE

    K Number: K844714 · Decision Feb 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    SELECTRON LDR SELECTRON LOW DOSE RATE
    K Number
    K844714
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Radiochemical Co.
    Date Received
    December 3, 1984
    Decision Date
    February 26, 1985
    Product Code
    JAQ
    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
    JAQ System, Applicator, Radionuclide, Remote-Controlled

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