BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480

    K Number: K911584 · Decision Oct 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    8
    Review Days
    199

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    Basic Information

    Device Name
    DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480
    K Number
    K911584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Pie Medical Equipment B.V.
    Date Received
    April 8, 1991
    Decision Date
    October 24, 1991
    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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