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

    XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES

    K Number: K061269 · Decision Aug 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    58
    Review Days
    101

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    Basic Information

    Device Name
    XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
    K Number
    K061269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Excel Tech. , Ltd.
    Date Received
    May 5, 2006
    Decision Date
    August 14, 2006
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

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    Other Clearances by Excel Tech. , Ltd.

    K Number Device Name
    K062549 XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
    K053386 XLTEK EMU40 EEG HEADBOX, MODEL PK1072
    K053058 XLTEK NEUROPATH, MODEL PK1070
    K052112 XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
    K052111 XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
    K042223 XLTEK CONNEX IP HEADBOX, MODEL 1054
    K042150 XLTEK TREX MODEL#10309
    K040358 XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
    K040360 EMU128S, MODEL EX-NW-128S
    K022037 XLTEK SLEEP SYSTEM
    Search all 58 clearances from Excel Tech. , Ltd. →