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

    AMBULATORY INFUSION PUMP, MODEL AS30C

    K Number: K863864 · Decision Feb 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    844
    Applicant Total
    206
    Review Days
    124

    Basic Information

    Device Name
    AMBULATORY INFUSION PUMP, MODEL AS30C
    K Number
    K863864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    TRAVENOL LABORATORIES, S.A.
    Date Received
    October 3, 1986
    Decision Date
    February 4, 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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