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

    OEC 9900 ELITE

    K Number: K073543 · Decision May 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    7
    Review Days
    137

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    Basic Information

    Device Name
    OEC 9900 ELITE
    K Number
    K073543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Oec Medical Systems
    Date Received
    December 17, 2007
    Decision Date
    May 2, 2008
    Product Code
    OWB
    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
    OWB Interventional Fluoroscopic X-Ray System

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