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

    TA-2 TEMPERATURE ALARM

    K Number: K770984 · Decision Jul 5, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    4
    Review Days
    35

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    Basic Information

    Device Name
    TA-2 TEMPERATURE ALARM
    K Number
    K770984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Mistogen Equipment Co.
    Date Received
    May 31, 1977
    Decision Date
    July 5, 1977
    Product Code
    BZE
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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    Other Clearances by Mistogen Equipment Co.

    K Number Device Name
    K801619 MIST2GEN TEMPTROL 10
    K781591 NEBULIZER/HUMIDIFIER MODEL EH 147B
    K760341 HUMIDIFIER, ELECTRONIC (EH147)