BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    GE VENUE 40, MODEL 5324338

    K Number: K091164 · Decision May 5, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    12
    Review Days
    13

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    Basic Information

    Device Name
    GE VENUE 40, MODEL 5324338
    K Number
    K091164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems China Co., Ltd.
    Date Received
    April 22, 2009
    Decision Date
    May 5, 2009
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Ge Medical Systems China Co., Ltd.

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