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

    AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI

    K Number: K041963 · Decision Oct 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    5
    Review Days
    91

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    Basic Information

    Device Name
    AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI
    K Number
    K041963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Bantex Corp.
    Date Received
    July 21, 2004
    Decision Date
    October 20, 2004
    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 American Bantex Corp.

    K Number Device Name
    K042104 AMERICAN BANTEX, MODEL MS 3
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    K963218 BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE