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

    XLTEK EMU40 EEG HEADBOX, MODEL PK1072

    K Number: K053386 · Decision Apr 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    188
    Applicant Total
    58
    Review Days
    137

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    XLTEK EMU40 EEG HEADBOX, MODEL PK1072
    K Number
    K053386
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Excel Tech. , Ltd.
    Date Received
    December 5, 2005
    Decision Date
    April 21, 2006
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GWQ), ordered by most recent decision date.

    Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

    FDA 510(k)
    FDA Class 2 ·Neurology

    New Wave System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Flexset System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Neuronaute Plus

    FDA 510(k)
    FDA Class 2 ·Neurology

    Q21

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPARK Scan

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Excel Tech. , Ltd.

    K Number Device Name
    K062549 XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
    K061269 XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
    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. →