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

    HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309

    K Number: K872364 · Decision Oct 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    206
    Review Days
    117

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    Basic Information

    Device Name
    HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
    K Number
    K872364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    June 18, 1987
    Decision Date
    October 13, 1987
    Product Code
    FII
    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
    FII System, Dialysate Delivery, Sealed

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