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

    MINI 6800 DIGITAL MOBILE C-ARM

    K Number: K992506 · Decision Aug 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    10
    Review Days
    23

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    Basic Information

    Device Name
    MINI 6800 DIGITAL MOBILE C-ARM
    K Number
    K992506
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Dec Medical Systems
    Date Received
    July 27, 1999
    Decision Date
    August 19, 1999
    Product Code
    OXO
    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
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

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