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

    ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS

    K Number: K852228 · Decision Sep 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    5
    Review Days
    104

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    Basic Information

    Device Name
    ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS
    K Number
    K852228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Sensortek, Inc.
    Date Received
    May 22, 1985
    Decision Date
    September 3, 1985
    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 Sensortek, Inc.

    K Number Device Name
    K864345 NTE-2 THERMAL SENSITIVITY TESTER
    K863607 VIBRATRON II, VIBRATION SENSITIVITY TESTER
    K844056 THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM
    K844055 ESOPHAGEAL STETHO SCOPE