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

    FLEXIFLO COMPANION ENTERAL NUTRITION PUMP

    K Number: K873119 · Decision Nov 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    87

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    Basic Information

    Device Name
    FLEXIFLO COMPANION ENTERAL NUTRITION PUMP
    K Number
    K873119
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Frantz Medical Development, Ltd.
    Date Received
    August 10, 1987
    Decision Date
    November 5, 1987
    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 Frantz Medical Development, Ltd.

    K Number Device Name
    K981541 CLEARSTAR ENTERAL NUTRITION PUMP
    K905282 ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
    K871710 BIOPSY FORCEPS
    K863508 FRANTZ MEDICAL ELECTRODE