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

    AIRWAY TEMPERATURE SENSOR

    K Number: K821505 · Decision Dec 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    17
    Review Days
    203

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    Basic Information

    Device Name
    AIRWAY TEMPERATURE SENSOR
    K Number
    K821505
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Mon-A-Therm, Inc.
    Date Received
    May 20, 1982
    Decision Date
    December 9, 1982
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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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
    K853392 MON-A-THERM SUBCUTANEOUS TEMP. SENSOR
    Search all 17 clearances from Mon-A-Therm, Inc. →