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

    CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE

    K Number: K012886 · Decision Oct 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    2
    Review Days
    42

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    Basic Information

    Device Name
    CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE
    K Number
    K012886
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cbyon, Inc.
    Date Received
    August 28, 2001
    Decision Date
    October 9, 2001
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

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