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

    AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER

    K Number: K041418 · Decision Jun 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    32
    Review Days
    14

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    Basic Information

    Device Name
    AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
    K Number
    K041418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinalhealth
    Date Received
    May 27, 2004
    Decision Date
    June 10, 2004
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAF Nebulizer (Direct Patient Interface)

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