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

    XLTEK NEUROPATH, MODEL PK1070

    K Number: K053058 · Decision Feb 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    26
    Applicant Total
    58
    Review Days
    99

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    Basic Information

    Device Name
    XLTEK NEUROPATH, MODEL PK1070
    K Number
    K053058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Excel Tech. , Ltd.
    Date Received
    October 31, 2005
    Decision Date
    February 7, 2006
    Product Code
    JXE
    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
    JXE Device, Nerve Conduction Velocity Measurement

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