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

    CKHEMO, MODEL CKHEMO VERSION 1.0

    K Number: K992255 · Decision Nov 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    49
    Applicant Total
    1
    Review Days
    147

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    Basic Information

    Device Name
    CKHEMO, MODEL CKHEMO VERSION 1.0
    K Number
    K992255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Csam, Inc.
    Date Received
    July 6, 1999
    Decision Date
    November 30, 1999
    Product Code
    FKP
    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
    FKP System, Dialysate Delivery, Single Patient

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