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

    XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16

    K Number: K992313 · Decision Aug 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    58
    Review Days
    41

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    Basic Information

    Device Name
    XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
    K Number
    K992313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Excel Tech. , Ltd.
    Date Received
    July 9, 1999
    Decision Date
    August 19, 1999
    Product Code
    GWF
    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
    GWF Stimulator, Electrical, Evoked Response

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