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

    ULTRASOUND SCANNER MINI FOCUS, MODEL 1402

    K Number: K043554 · Decision Jan 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    7
    Review Days
    18

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    Basic Information

    Device Name
    ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
    K Number
    K043554
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B-K Medical A/S
    Date Received
    December 27, 2004
    Decision Date
    January 14, 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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    Other Clearances by B-K Medical A/S

    K Number Device Name
    K043524 ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
    K024236 ULTRASOUND SCANNER, TYPE 2400
    K023457 ULTRASOUND SCANNER, TYPE 1101
    K011417 ULTRASOUND SCANNER, TYPE 2102
    K003986 ULTRASOUND SCANNER TYPE 2102
    K003041 ULTRASOUND SCANNER TYPE 2101