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

    GAMBRO LUNDIA ALPHA HEMODIALYZERS

    K Number: K915504 · Decision Mar 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    35
    Applicant Total
    11
    Review Days
    88

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    Basic Information

    Device Name
    GAMBRO LUNDIA ALPHA HEMODIALYZERS
    K Number
    K915504
    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
    December 9, 1991
    Decision Date
    March 6, 1992
    Product Code
    FJG
    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
    FJG Dialyzer, Parallel Flow

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

    K Number Device Name
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    K925522 CENTRYSYSTEM 3 WITH CHARTS/BP OPTION
    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)
    K911603 HEMOSPAL KIT B22
    Search all 11 clearances from C.G.H. Medical, Inc. →