BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags

    K Number: K170150 · Decision Oct 20, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    276

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    Basic Information

    Device Name
    Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
    K Number
    K170150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S.A.L.F. Spa
    Date Received
    January 17, 2017
    Decision Date
    October 20, 2017
    Product Code
    KDL
    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
    KDL Set, Perfusion, Kidney, Disposable

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    Other Clearances by S.A.L.F. Spa

    K Number Device Name
    K230193 Servator P Plus SALF Solution
    K211842 Servator M SALF Solution
    K202652 Servator P SALF Solution with THAM
    K190063 Servator C SALF Solution
    K180481 Servator B SALF Solution