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

    USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM

    K Number: K031502 · Decision Aug 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    472

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    Basic Information

    Device Name
    USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
    K Number
    K031502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Usfilter
    Date Received
    May 13, 2003
    Decision Date
    August 27, 2004
    Product Code
    FIN
    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
    FIN Tank, Holding, Dialysis

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