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

    SELECTRA AND TUBING SETS

    K Number: K910173 · Decision Jan 13, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    6
    Review Days
    363

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    Basic Information

    Device Name
    SELECTRA AND TUBING SETS
    K Number
    K910173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medionics International , Ltd.
    Date Received
    January 15, 1991
    Decision Date
    January 13, 1992
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

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    Other Clearances by Medionics International , Ltd.

    K Number Device Name
    K883393 CAPD DISPOSABLE Y SYSTEM - DY SET
    K842305 C.A.P.D. AUTOMATIC HEATER PDH 200
    K831766 MICROSTAR VCI
    K832141 MICROSTAR VC1 VOLUMETRIC CYCLER
    K821328 C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP