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510(k) Data Aggregation

    K Number
    K202174
    Device Name
    Digital NeuroPort Biopotential Signal Processing System
    Manufacturer
    Blackrock Microsystems
    Date Cleared
    2021-02-10

    (190 days)

    Product Code
    GWL, GWK
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    Blackrock Microsystems

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital NeuroPort Biopotential Signal Processing System supports recording, processing, and display of biopotential signals from user-supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electroculography (EOG), and Evoked Potential (EP).
    Device Description
    The Digital NeuroPort Biopotential Signal Processing System is used to acquire, process, visualize, archive/record signals as acquired from user-supplied electrodes for biopotential monitoring. Signals are acquired using a headstage relay that attaches to the pedestal interface and digitizes the signal through the hub. The Digital NeuroPort System uses preamplifiers, analog to digital converters, a signal processing unit, and software running on a personal computer to visualize and record biopotentials from electrodes in contact with the body.
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    K Number
    K191346
    Device Name
    Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
    Manufacturer
    Blackrock Microsystems
    Date Cleared
    2020-02-14

    (270 days)

    Product Code
    GYC
    Regulation Number
    882.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Blackrock Microsystems

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
    Device Description
    Cortical Electrode (Per FDA Classification)
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    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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