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510(k) Data Aggregation

    K Number
    K110010
    Device Name
    NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
    Manufacturer
    BLACKROCK MICROSYSTEMS, INC
    Date Cleared
    2011-02-09

    (37 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLACKROCK MICROSYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroPort™ Electrode (SIROF) 1.0 mm and 1.5 mm are indicated for temporary (<30 days) recording and monitoring of brain electrical activity.
    Device Description
    The NeuroPort™ Electrode (SIROF) detects the electrical activity of cortical neurons during sub-chronic-monitoring procedures for less than thirty consecutive days. All of the components in the NeuroPort™ Electrode (SIROF) are passive and are intended exclusively for recording applications: monitoring brain electrical activity, defining the location of the epileptogenic foci and brain mapping. The NeuroPort™ Electrode (SIROF) consists of high impedance electrodes. The NeuroPort™ Electrode (SIROF) has 100 electrode contacts on a silicon substrate of 4mm by 4mm. The electrodes provide the patient contact device. The electrodes connect the users recording and monitoring equipment. The electrodes are used under the supervision of a physician. Physicians in the areas of biopotential recording and monitoring understand the use of depth electrodes.
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