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510(k) Data Aggregation

    K Number
    K023472
    Device Name
    LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
    Manufacturer
    CLASS A ENTERPRISES, INC.
    Date Cleared
    2003-03-18

    (153 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLASS A ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Electroencephalograph (EEG) needle electrodes are needles intended to be inserted into the subdermal tissue of the scalp to sense the minute electrical signals (waveforms) of the brain. This device is an accessory to the electroencephalograph machine, which is for use in connection with neurological studies. EEG electrodes are indicated for use by or on the order of a licensed physician and intended for single patient use, only.
    Device Description
    Disposable EEG Needle Electrode
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