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

    XLTEK TREX MODEL#10309

    K Number: K042150 · Decision Aug 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    188
    Applicant Total
    58
    Review Days
    18

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    Basic Information

    Device Name
    XLTEK TREX MODEL#10309
    K Number
    K042150
    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 9, 2004
    Decision Date
    August 27, 2004
    Product Code
    GWQ
    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
    GWQ Full-Montage Standard Electroencephalograph

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    Other Clearances by Excel Tech. , Ltd.

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    K052111 XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
    K042223 XLTEK CONNEX IP HEADBOX, MODEL 1054
    K040358 XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
    K040360 EMU128S, MODEL EX-NW-128S
    K022037 XLTEK SLEEP SYSTEM
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