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

    HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS

    K Number: K860336 · Decision Mar 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    34

    Basic Information

    Device Name
    HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
    K Number
    K860336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    BREEM LABORATORIES
    Date Received
    January 29, 1986
    Decision Date
    March 4, 1986
    Product Code
    FKQ
    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
    FKQ System, Dialysate Delivery, Central Multiple Patient

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FKQ), ordered by most recent decision date.

    DIACAP ULTRA DIALYSIS FLUID FILTER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TWO TANK DISSOLUTION MODULE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KAWASUMI A.V. FISTULA SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACID FUCHSIN SOLUTIONS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACTRIL FOR KIDNEY MACHINE DISINFECTANT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all