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

    DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD

    K Number: K843963 · Decision Jan 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    35
    Review Days
    88

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    Basic Information

    Device Name
    DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
    K Number
    K843963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Renal Systems, Inc.
    Date Received
    October 11, 1984
    Decision Date
    January 7, 1985
    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

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    Other Clearances by Renal Systems, Inc.

    K Number Device Name
    K970648 PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
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    K854011 RENALFO HEMOFILTER CAVHD
    K844790 RENAFLO HEMOCONCENTRATOR
    K844108 RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
    K842258 RENATRON
    K841543 CONCENTRATE CONDUCTIVITY METER
    K840182 RENAPAK CONCENTRATE MIXING SYS.
    K840437 HEMASITE ACCESSORIES MODIFICATION
    K840436 HEMASITE/RENALOY -VASCULAR ACCESS SHUNT
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