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

    ULTRASYSTEM LINSCAN PROBE

    K Number: K842811 · Decision Sep 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    1
    Review Days
    61

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    Basic Information

    Device Name
    ULTRASYSTEM LINSCAN PROBE
    K Number
    K842811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Kelley Development Corp.
    Date Received
    July 18, 1984
    Decision Date
    September 17, 1984
    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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