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

    CENTRYSYSTEM 3 WITH CHARTS/BP OPTION

    K Number: K925522 · Decision Sep 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    11
    Review Days
    697

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    Basic Information

    Device Name
    CENTRYSYSTEM 3 WITH CHARTS/BP OPTION
    K Number
    K925522
    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
    November 2, 1992
    Decision Date
    September 30, 1994
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

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    Other Clearances by C.G.H. Medical, Inc.

    K Number Device Name
    K941708 COBE CENTRYSYSTEM CS500 DIALYZER
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    K920757 FILTRAL HEMODIALYZERS
    K931720 LUNDIA ALPHA 700 HEMODIALYZER
    K924437 HEMOSPAL KIT B22 / MULTIFLOW 60 KIT
    K940601 GAMBRO BICART 720G
    K915154 GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS
    K914271 GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)
    K915504 GAMBRO LUNDIA ALPHA HEMODIALYZERS
    K911603 HEMOSPAL KIT B22
    Search all 11 clearances from C.G.H. Medical, Inc. →