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

    CIDEX*DIALYZER DISINFECTING SOLUTION

    K Number: K822535 · Decision Sep 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    56
    Review Days
    37

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    Basic Information

    Device Name
    CIDEX*DIALYZER DISINFECTING SOLUTION
    K Number
    K822535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Surgikos, Inc.
    Date Received
    August 24, 1982
    Decision Date
    September 30, 1982
    Product Code
    FKQ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    CH
    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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