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

    THERMODILUTION KIT

    K Number: K811480 · Decision Jun 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    36
    Applicant Total
    64
    Review Days
    13

    Basic Information

    Device Name
    THERMODILUTION KIT
    K Number
    K811480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1915
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    AMERICAN PHARMASEAL DIV. AHSC
    Date Received
    May 27, 1981
    Decision Date
    June 9, 1981
    Product Code
    KRB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRB Probe, Thermodilution

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