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

    FUKUDA DENSHI MODEL UF-850XTD

    K Number: K050363 · Decision Feb 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    1117
    Applicant Total
    66
    Review Days
    3

    Basic Information

    Device Name
    FUKUDA DENSHI MODEL UF-850XTD
    K Number
    K050363
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FUKUDA DENSHI USA, INC.
    Date Received
    February 14, 2005
    Decision Date
    February 17, 2005
    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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