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

    INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S

    K Number: K011155 · Decision Jul 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
    K Number
    K011155
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ibt, Inc.
    Date Received
    April 16, 2001
    Decision Date
    July 12, 2001
    Product Code
    KXK
    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
    KXK Source, Brachytherapy, Radionuclide

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