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

    SUBDERMAL NEEDLE ELECTRODES

    K Number: K072276 · Decision May 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    275

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    Basic Information

    Device Name
    SUBDERMAL NEEDLE ELECTRODES
    K Number
    K072276
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1350
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xian Friendship Electronics Co., Ltd.
    Date Received
    August 15, 2007
    Decision Date
    May 16, 2008
    Product Code
    GXZ
    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
    GXZ Electrode, Needle

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