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

    EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

    K Number: K032503 · Decision Aug 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    100
    Review Days
    9

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    Basic Information

    Device Name
    EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
    K Number
    K032503
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Medical Systems America, Inc.
    Date Received
    August 13, 2003
    Decision Date
    August 22, 2003
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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