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

    KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS

    K Number: K040196 · Decision May 5, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    33
    Applicant Total
    4
    Review Days
    97

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    Basic Information

    Device Name
    KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
    K Number
    K040196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyco Healthcare/Kendall
    Date Received
    January 29, 2004
    Decision Date
    May 5, 2004
    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 Tyco Healthcare/Kendall

    K Number Device Name
    K060339 KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
    K051805 KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE
    K040511 SCD EXPRESS PORTABLE COMPRESSION SYSTEM