BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT

    K Number: K854555 · Decision Mar 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    3
    Review Days
    118

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    Basic Information

    Device Name
    GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT
    K Number
    K854555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Gl Ultrasound , Ltd.
    Date Received
    November 14, 1985
    Decision Date
    March 12, 1986
    Product Code
    IYO
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Gl Ultrasound , Ltd.

    K Number Device Name
    K844393 GL ULTRASOUND SECTOR 170
    K843205 GL ULTRASOUND Z/SL 8300