BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    ULTRASOUND SCANNER TYPE 2101

    K Number: K003041 · Decision Feb 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    345
    Registration Numbers
    346
    Same Product Code
    883
    Applicant Total
    7
    Review Days
    131

    Basic Information

    Device Name
    ULTRASOUND SCANNER TYPE 2101
    K Number
    K003041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B-K MEDICAL A/S
    Date Received
    September 29, 2000
    Decision Date
    February 7, 2001
    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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