BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    FLEXIFLO 6.1 ENTERAL NUTRITION PUMP

    K Number: K951429 · Decision Dec 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    33
    Applicant Total
    4
    Review Days
    269

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    Basic Information

    Device Name
    FLEXIFLO 6.1 ENTERAL NUTRITION PUMP
    K Number
    K951429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Ross Products
    Date Received
    March 28, 1995
    Decision Date
    December 22, 1995
    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 Products

    K Number Device Name
    K011467 ROSS EMBRACE PUMP SET
    K972437 ROSS ENTERAL FEEDING TUBE
    K950017 FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM