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

    THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM

    K Number: K844056 · Decision Jan 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    83

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    Basic Information

    Device Name
    THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM
    K Number
    K844056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sensortek, Inc.
    Date Received
    October 18, 1984
    Decision Date
    January 9, 1985
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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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
    K852228 ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS
    K844055 ESOPHAGEAL STETHO SCOPE