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

    ROSS EMBRACE ENTERAL PUMP

    K Number: K031407 · Decision May 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    33
    Applicant Total
    4
    Review Days
    15

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    Basic Information

    Device Name
    ROSS EMBRACE ENTERAL PUMP
    K Number
    K031407
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ross Product Div. Abbott Laboratories
    Date Received
    May 5, 2003
    Decision Date
    May 20, 2003
    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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    Other Clearances by Ross Product Div. Abbott Laboratories

    K Number Device Name
    K003047 AMBULATORY ENTERAL NUTRITION PUMP
    K992494 FLEXIFLO ENTERAL FEEDING TUBE
    K990863 MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE