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510(k) Data Aggregation

    K Number
    K121119
    Device Name
    BNA ANALYSIS SYSTEM
    Manufacturer
    EIMINDA LTD.
    Date Cleared
    2014-07-25

    (834 days)

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

    EIMINDA LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BNA™ Analysis System is to be used by qualified medical professionals for the posthoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP"). This device is indicated for use in individuals 14 to 24 years of age. The BNA™ Analysis System is to be used with the auditory oddball task only.
    Device Description
    The BNA Analysis System is an accessory to EEG. The BNA Analysis System is a software device that is used to analyze EEG-ERP data with regards to conventional, well established characteristics of amplitude and latency. Statistical analysis is performed to express the differences between the patient (individual) and a task-matched reference group in the indicated age group in the form of Z-scores. The BNA Analysis System report displays the test results in the following format; (1) Test and Patient Information; (2) ERP waveforms; (3) Summarized patient results - Z-Score Tables, Z-Score Maps and BNA Composite Scores. BNA Composite Scores are a calculation of the global comparison of the individual to the normative group (RBNM) for the following well-established EEG-ERP components: amplitude and absolute time. These calculations are a measure of the overall similarity of the single subject EEG-ERP components to the EEG-ERP components of the normative group (RBNM) based on Z-scores. The BNA scores should not be used as stand-alone information: rather, such scores should complement all of the information included in the report, as well as the clinical evaluation.
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