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

    Jmoon Conductive Gel

    K Number: K243749 · Decision Apr 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    68
    Applicant Total
    23
    Review Days
    124

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    Basic Information

    Device Name
    Jmoon Conductive Gel
    K Number
    K243749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1275
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Received
    December 5, 2024
    Decision Date
    April 8, 2025
    Product Code
    GYB
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GYB Media, Electroconductive

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