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

    Ultrasound System 1300

    K Number: K231764 · Decision Oct 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    9
    Review Days
    129

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    Basic Information

    Device Name
    Ultrasound System 1300
    K Number
    K231764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bk Medical Aps
    Date Received
    June 16, 2023
    Decision Date
    October 23, 2023
    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 Bk Medical Aps

    K Number Device Name
    K223830 Ultrasound System 2300
    K222441 Ultrasound System 2300
    K180737 Ultrasound Scanner System bk2300
    K173569 Ultrasound System 1300
    K161960 bk2300
    K151910 Ultrasound Scanner System BK2300
    K152052 Ultrasound Scanner System bk2300
    K143298 Ultrasound Scanner System bk2300