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510(k) Data Aggregation

    K Number
    K991077
    Device Name
    MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
    Manufacturer
    MICRORECORDING SYSTEMS CONSULTANTS, LLC.
    Date Cleared
    1999-06-09

    (70 days)

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

    MICRORECORDING SYSTEMS CONSULTANTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of our µEEG™ Pro System 5000 is for temporary recording of intractanial neural activity, temporary intracranial stimulation of neurons, and mapping of neural activity and evoked potentials. uEEG™ Pro System 5000 Is indicated for use during intracranial neurophysiological recording and stimulation during deep brain stimulation, epilepsy surgery, and other procedures where it is appropriate to perform intracranial depth or subdural electrode recordings.
    Device Description
    Not Found
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