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

    MON-A-THERM MYOCARDIAL TEMP. SENSOR

    K Number: K823435 · Decision Dec 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    36
    Applicant Total
    10
    Review Days
    44

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    Basic Information

    Device Name
    MON-A-THERM MYOCARDIAL TEMP. SENSOR
    K Number
    K823435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1915
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Burditt & Calkins-Siemens-Elema
    Date Received
    November 16, 1982
    Decision Date
    December 30, 1982
    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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