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

    ENTECH ENTERAL PUMP AND SET

    K Number: K873444 · Decision Nov 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    7
    Review Days
    67

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    Basic Information

    Device Name
    ENTECH ENTERAL PUMP AND SET
    K Number
    K873444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Entech, Inc.
    Date Received
    August 27, 1987
    Decision Date
    November 2, 1987
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    Other Clearances by Entech, Inc.

    K Number Device Name
    K891371 GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG
    K890430 ENTAINER(TM) ENTERAL FEEDING CONTAINER
    K873343 ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM
    K871019 ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET
    K861427 ENTUBE TM, ENTERAL FEEDING TUBE
    K861552 TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS