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

    ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY

    K Number: K851245 · Decision May 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    49

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    Basic Information

    Device Name
    ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY
    K Number
    K851245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Applinc
    Date Received
    March 27, 1985
    Decision Date
    May 15, 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
    K842597 RESPIRATORY GAS HUMIDIFIER