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510(k) Data Aggregation

    K Number
    K974718
    Device Name
    PERSYST PRISM
    Manufacturer
    PERSYST DEVELOPMENT CORP.
    Date Cleared
    1998-03-09

    (82 days)

    Product Code
    GWS, GMS
    Regulation Number
    882.1420
    Why did this record match?
    Product Code :

    GWS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use by a trained EEG reader. This software is intended for use by a trained EEG technician or neurologist.
    Device Description
    The Persyst Prism is a software only product. It runs on a personal computer and requires no specialized hardware. It displays digitized EEG signals, power spectra, topographic maps, etc. These functions are all controlled and interpreted by the digitized EEG input is read from a file on the personal computer (or available across the network). Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.
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