BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇿🇦 South Africa

    MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)

    K Number: K011111 · Decision May 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    1
    Review Days
    49

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    Basic Information

    Device Name
    MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
    K Number
    K011111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Modular X-Ray Devices
    Date Received
    April 11, 2001
    Decision Date
    May 30, 2001
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

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