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

    TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER

    K Number: K862548 · Decision Oct 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    4
    Review Days
    111

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    Basic Information

    Device Name
    TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER
    K Number
    K862548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Lawrence Medical Systems, Inc.
    Date Received
    July 3, 1986
    Decision Date
    October 22, 1986
    Product Code
    BZT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZT Stethoscope, Esophageal, With Electrical Conductors

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    Other Clearances by Lawrence Medical Systems, Inc.

    K Number Device Name
    K874492 LAWRENCE L4000 REFLECTANCE PULSE OXIMETER
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    K851426 ACCUCOM CARDIAC OUTPUT MONITOR