BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    HEMOCONCENTRATOR

    K Number: K123288 · Decision Jun 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    44
    Review Days
    247

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    Basic Information

    Device Name
    HEMOCONCENTRATOR
    K Number
    K123288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maquet Cardiopulmonary, AG
    Date Received
    October 22, 2012
    Decision Date
    June 26, 2013
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    K132829 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
    K131666 ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
    K130300 HEATER-COOLER UNIT HCU 40
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