BEUDAMED
    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

    System, Imaging, Pulsed Doppler, Ultrasonic

    PMA: P940005 · Decision Apr 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211

    Basic Information

    Device Name
    System, Imaging, Pulsed Doppler, Ultrasonic
    Trade Name
    ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM
    PMA Number
    P940005
    Device Class
    FDA Class 2
    Product Code
    IYN
    Generic Name
    System, imaging, pulsed doppler, ultrasonic
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    April 11, 1996
    Date Received
    February 17, 1994
    Expedited Review
    Y
    Docket Number
    96M-0450

    Advisory Committee Statement

    APPROVAL FOR THE ULTRAMARK 9 HIGH DEFINITION IMAGING (HDI) ULTRASOUND SYSTEM WITH L10-5 SCANHEAD

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

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