BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CYBERREN

    K Number: K970989 · Decision Jul 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    128

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    Basic Information

    Device Name
    CYBERREN
    K Number
    K970989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cybernius Medical , Ltd.
    Date Received
    March 18, 1997
    Decision Date
    July 24, 1997
    Product Code
    KPF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal

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