BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    KOLO Evolution XHD Series Ultrasound Diagnostic System

    K Number: K221568 · Decision Sep 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    1
    Review Days
    104

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    Basic Information

    Device Name
    KOLO Evolution XHD Series Ultrasound Diagnostic System
    K Number
    K221568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kolo Medical (Suzhou) Co., Ltd.
    Date Received
    May 31, 2022
    Decision Date
    September 12, 2022
    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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