BEUDAMED
    Product Code: GWR FDA class 1 21 CFR 882.1430

    Generator, Electroencephalograph Test Signal

    Neurology

    The Generator, Electroencephalograph Test Signal is a calibration device that produces standardized electrical test signals used to verify and calibrate electroencephalograph (EEG) equipment, ensuring accurate recording of brain electrical activity in clinical and research settings. It is an FDA Class 1 device, subject only to general controls with no premarket submission required. The product code is GWR, regulated under 21 CFR 882.1430 in the Neurology specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GWR
    Device Class
    FDA class 1
    Regulation Number
    882.1430
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.