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

    GT5 conductive & abrasive gel

    K Number: K212787 · Decision Nov 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    68
    Applicant Total
    2
    Review Days
    68

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    Basic Information

    Device Name
    GT5 conductive & abrasive gel
    K Number
    K212787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1275
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wuhan Greentek Pty , Ltd.
    Date Received
    September 1, 2021
    Decision Date
    November 8, 2021
    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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