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

    Navi e/Navi s/Navi X Diagnostic Ultrasound System

    K Number: K180461 · Decision May 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    7
    Review Days
    78

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    Basic Information

    Device Name
    Navi e/Navi s/Navi X Diagnostic Ultrasound System
    K Number
    K180461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Wisonic Medical Technology Co. , Ltd.
    Date Received
    February 20, 2018
    Decision Date
    May 9, 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 Wisonic Medical Technology Co. , Ltd.

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