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

    ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A

    K Number: K090002 · Decision Aug 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    505
    Review Days
    217

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    Basic Information

    Device Name
    ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
    K Number
    K090002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Healthcare Corp
    Date Received
    January 2, 2009
    Decision Date
    August 7, 2009
    Product Code
    KPO
    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
    KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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