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

    Sterile and Non-Sterile Ultrasound Gels

    K Number: K232957 · Decision Dec 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    Sterile and Non-Sterile Ultrasound Gels
    K Number
    K232957
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jianerkang Medical Co., Ltd.
    Date Received
    September 21, 2023
    Decision Date
    December 15, 2023
    Product Code
    MUI
    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
    MUI Media, Coupling, Ultrasound

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