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510(k) Data Aggregation

    K Number
    K970989
    Device Name
    CYBERREN
    Manufacturer
    CYBERNIUS MEDICAL LTD.
    Date Cleared
    1997-07-24

    (128 days)

    Product Code
    KPF
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYBERNIUS MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    cyberREN is a clinical data management system, designed specifically for nephrology, to replace the paper medical chart. Full chart replacement, i.e. a conversion from a paper medical record to an electronic medical record is at the option of the client. The cyberREN electronic chart essentially provides the functions of a data repository and data query / reporting system.
    Device Description
    cyberREN is a clinical data management system designed for nephrology. It functions as a data repository and data query/reporting system, intended to replace paper medical charts. It is a multiuser, multidisciplinary system accessible via standard Windows 95 based computers. It saves, calculates, displays, and reports clinical information. Data is primarily entered manually by caregivers, but can also be received from networked systems like laboratory computers and dialysis machines (specifically the Fresenius 2008H). It calculates values such as weight gain, protein catabolic rate, percent urea reduction, KT/V dialysis efficacy index, and nutrition parameters. It supports general charting functions like patient demographics, problem lists, orders, medications, progress notes, consultations, and laboratory results reporting. It also supports charting for hemodialysis (treatment orders, session charting, access charting, scheduling) and peritoneal dialysis (orders, session charting, peritonitis charting, access charting). It can also be used to document transplant status and workup activities. cyberREN does not alter entered information, make treatment recommendations, influence dialysis machine operation, or provide diagnoses.
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