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

    Electrosurgical disposable grounding pads

    K Number: K160366 · Decision Aug 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    192

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    Basic Information

    Device Name
    Electrosurgical disposable grounding pads
    K Number
    K160366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Top-Rank Health Care Co., Ltd.
    Date Received
    February 9, 2016
    Decision Date
    August 19, 2016
    Product Code
    ODR
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ODR Electrosurgical Patient Return Electrode

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