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510(k) Data Aggregation

    K Number
    K061515
    Device Name
    RENALSOFT
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    2006-09-11

    (102 days)

    Product Code
    KPF, FKP
    Regulation Number
    876.5630
    Why did this record match?
    Product Code :

    KPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Renal Soft is designed specifically for nephrology and offers an electronic alternative to the paper medical chart. RenalSoft provides the functions of a data repository and data query/reporting system. This software is not intended to be a substitute for good clinical management practices nor does its operation create decisions or treatment pathways.
    Device Description
    RenalSoft is designed specifically for nephrology and offers an electronic alternative to the paper medical chart, in accordance with local regulations. RenalSoft provides the functions of a data repository and data query/reporting system. RenalSoft is a clinical tool that organizes dialysis therapy data to facilitate clinician decision-making and patient care.
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    K Number
    K990953
    Device Name
    RENAL LINK
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    1999-06-18

    (88 days)

    Product Code
    KPF
    Regulation Number
    876.5630
    Why did this record match?
    Product Code :

    KPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Renal Therapy Clinical Data Management Software (Renal Link) is designed specifically for nephrology and offers an alternative to the paper medical chart. Renal Link provides the functions of a data repository and data query/reporting system.
    Device Description
    Renal Link Clinical Data Management Software (Renal Link) is a software accessory to a medical device based on relational database technology, the same technology as that used by the predicate device.
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    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?
    Product Code :

    KPF

    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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    K Number
    K955762
    Device Name
    PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1996-07-31

    (226 days)

    Product Code
    KPF
    Regulation Number
    876.5630
    Why did this record match?
    Product Code :

    KPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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