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

    FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP

    K Number: K913958 · Decision Feb 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    33
    Applicant Total
    883
    Review Days
    155

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    Basic Information

    Device Name
    FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
    K Number
    K913958
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Abbott Laboratories
    Date Received
    September 5, 1991
    Decision Date
    February 7, 1992
    Product Code
    LZH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZH Pump, Infusion, Enteral

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