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

    XLTEK CONNEX IP HEADBOX, MODEL 1054

    K Number: K042223 · Decision Sep 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    40
    Applicant Total
    58
    Review Days
    30

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    Basic Information

    Device Name
    XLTEK CONNEX IP HEADBOX, MODEL 1054
    K Number
    K042223
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Excel Tech. , Ltd.
    Date Received
    August 17, 2004
    Decision Date
    September 16, 2004
    Product Code
    OMB
    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
    OMB Automatic Event Detection Software For Full-Montage Electroencephalograph

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