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

    KOALA C99 I.V. CONTROLLER

    K Number: K830780 · Decision Apr 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    59
    Applicant Total
    33
    Review Days
    28

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    Basic Information

    Device Name
    KOALA C99 I.V. CONTROLLER
    K Number
    K830780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Chesebrough-Pond'S U.S.A. Co.
    Date Received
    March 11, 1983
    Decision Date
    April 8, 1983
    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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