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

    RESPIRATORY GAS HUMIDIFIER

    K Number: K842597 · Decision Jan 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    197

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    Basic Information

    Device Name
    RESPIRATORY GAS HUMIDIFIER
    K Number
    K842597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Applinc
    Date Received
    July 3, 1984
    Decision Date
    January 16, 1985
    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 Applinc

    K Number Device Name
    K851245 ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY