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

    THERMAL DILUTION CATHETER

    K Number: K823484 · Decision Dec 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    321
    Review Days
    29

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    Basic Information

    Device Name
    THERMAL DILUTION CATHETER
    K Number
    K823484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Laboratory CO
    Date Received
    November 23, 1982
    Decision Date
    December 22, 1982
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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