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

    TRAVENOL INFUSION CONTROLLER 2M8052

    K Number: K812510 · Decision Sep 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    59
    Applicant Total
    206
    Review Days
    14

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    Basic Information

    Device Name
    TRAVENOL INFUSION CONTROLLER 2M8052
    K Number
    K812510
    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
    September 2, 1981
    Decision Date
    September 16, 1981
    Product Code
    LDR
    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
    LDR Controller, Infusion, Intravascular, Electronic

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    K872364 HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
    K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
    K871908 IV ADMINISTRATION SET
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