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

    HOSPAL DIALYSATE FOR C.A.V.H.D.

    K Number: K872857 · Decision Oct 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    27
    Review Days
    76

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    Basic Information

    Device Name
    HOSPAL DIALYSATE FOR C.A.V.H.D.
    K Number
    K872857
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Delmed, Inc.
    Date Received
    July 21, 1987
    Decision Date
    October 5, 1987
    Product Code
    KPO
    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
    KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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    Other Clearances by Delmed, Inc.

    K Number Device Name
    K895142 ENTERAL PUMP SET WITH ENTERAL SPIKE
    K895650 ENTERAL PUMP SET W/ENTERA-FLO SPIKE
    K895329 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA
    K894506 ENTERA-FLO ENTERAL FEEDING PUMP
    K901478 DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
    K901477 DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
    K900106 CLOSED DISCONNECT SYSTEM
    K895246 FRENTA(R) DUO-SET
    K895330 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA
    K895919 ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III
    Search all 27 clearances from Delmed, Inc. →