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

    Color Doppler Ultrasound System; Model: mEye1 and mEye2

    K Number: K182165 · Decision Dec 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    132

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    Basic Information

    Device Name
    Color Doppler Ultrasound System; Model: mEye1 and mEye2
    K Number
    K182165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Well.D Medical Electronics Co., Ltd.
    Date Received
    August 10, 2018
    Decision Date
    December 20, 2018
    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 Shenzhen Well.D Medical Electronics Co., Ltd.

    K Number Device Name
    K100079 DIGITAL ULTRASOUND SCANNER