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510(k) Data Aggregation

    K Number
    K050192
    Device Name
    BRC SOFTWARE PRODUCT
    Manufacturer
    BRC OPERATIONS PTY LIMITED
    Date Cleared
    2005-10-20

    (266 days)

    Product Code
    OLU, GWE, GWJ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRC OPERATIONS PTY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).
    Device Description
    The BRC software product is composed of the following major components: BRC The DRC software produisition Software and the BRC Neuromarker Analysis Software. Neuromarker Data Acquisition Software is used to collect the data gathered at BRC I he Nedromancer Data requisition protocols and equipment are utilized at each nechsed laboratory to ensure uniformity of collected data. The data is then transmitted to the DRC Central Analysis Facility where the Neuromarker Analysis Software is used to DIC Central Interfall Pagainst the Brain Resource International Database (BRID). The process the gatibled and againta from approximately 2,400 normative (i.e., without a database Currently contains ada cohol abuse, or serious medical condition) participants. The results of the processed data is compiled into an individualized report called the NeuroMarker Report. The BRC Cognition Acquisition Software is one component of the BRC NeuroMarker The DRC Cognition Frequence is loaded on a computerized touchscreen system and used to gather cognitive patient performance information. This data is transmitted from used to gamer cogment person personal Analysis Facility for processing and formatting into report form (IntegNeuro Report). The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).
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