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

    MON-A-THERM SUBCUTANEOUS TEMP. SENSOR

    K Number: K853392 · Decision Nov 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    17
    Review Days
    101

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    Basic Information

    Device Name
    MON-A-THERM SUBCUTANEOUS TEMP. SENSOR
    K Number
    K853392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mon-A-Therm, Inc.
    Date Received
    August 13, 1985
    Decision Date
    November 22, 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 Mon-A-Therm, Inc.

    K Number Device Name
    K885187 MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
    K874522 MODIFIED MYOCARDIAL TEMPERATURE SENSOR
    K874519 MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR
    K875234 MON-A-THERM'S SKIN TEMPERATURE SENSOR
    K874525 MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR
    K874524 MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR
    K874523 MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR
    K874521 MODIFIED THERMAL WELL TEMPERATURE SENSOR
    K874520 MODIFIED AIRWAY TEMPERATURE SENSOR
    K830819 MODIFICATION ELECTRONIC CLINICAL THERMO-
    Search all 17 clearances from Mon-A-Therm, Inc. →