BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COBE CENTRYSYSTEM CS500 DIALYZER

    K Number: K941708 · Decision May 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    11
    Review Days
    401

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    Basic Information

    Device Name
    COBE CENTRYSYSTEM CS500 DIALYZER
    K Number
    K941708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.G.H. Medical, Inc.
    Date Received
    April 6, 1994
    Decision Date
    May 12, 1995
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

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    K915154 GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS
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