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510(k) Data Aggregation
K Number
K050192Device Name
BRC SOFTWARE PRODUCT
Manufacturer
BRC OPERATIONS PTY LIMITED
Date Cleared
2005-10-20
(266 days)
Product Code
OLU, GWE, GWJ
Regulation Number
882.1400Why 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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