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    K Number
    K090957
    Device Name
    BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
    Manufacturer
    I2S MICRO IMPLANTABLE SYSTEMS, LLC
    Date Cleared
    2009-05-28

    (52 days)

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

    I2S MICRO IMPLANTABLE SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blackrock 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), electrooculography (EOG) and Evoked Potential (EP).
    Device Description
    The Blackrock NeuroPort Biopotential Signal Processing System (System), when connected to customer supplier bio-potential electrodes or the NeuroPort Electrode Array (K042384), supports recording and display of bio-potential signals. Bio-potential signals that can be recorded by the System include: 1. Electrooculography (EOG), 2. Electrocorticography (ECoG), 3. electroencephalography (EEG), 4. electromyography (EMG), 5. electroencephalography (ECG) and 6. evoked potential (EP). The System is not a monitoring system. No physiologic alarms are provided. The acquisition and display of bio-potential signals is for the interpretation and use of the clinician.
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