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

    MIST2GEN TEMPTROL 10

    K Number: K801619 · Decision Aug 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    4
    Review Days
    20

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    Basic Information

    Device Name
    MIST2GEN TEMPTROL 10
    K Number
    K801619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Mistogen Equipment Co.
    Date Received
    July 15, 1980
    Decision Date
    August 4, 1980
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Mistogen Equipment Co.

    K Number Device Name
    K781591 NEBULIZER/HUMIDIFIER MODEL EH 147B
    K770984 TA-2 TEMPERATURE ALARM
    K760341 HUMIDIFIER, ELECTRONIC (EH147)