BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382

    K Number: K052111 · Decision Aug 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    52
    Applicant Total
    58
    Review Days
    13

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    Basic Information

    Device Name
    XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
    K Number
    K052111
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.1350
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Excel Tech. , Ltd.
    Date Received
    August 4, 2005
    Decision Date
    August 17, 2005
    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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