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

    PARENTERAL INFUSION CONTROLLER

    K Number: K780223 · Decision Apr 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    206
    Review Days
    60

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    Basic Information

    Device Name
    PARENTERAL INFUSION CONTROLLER
    K Number
    K780223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    February 9, 1978
    Decision Date
    April 10, 1978
    Product Code
    FLN
    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
    FLN Monitor, Electric For Gravity Flow Infusion Systems

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