BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    AERONEB GO NEBULIZER

    K Number: K081650 · Decision Oct 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    2
    Review Days
    133

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    Basic Information

    Device Name
    AERONEB GO NEBULIZER
    K Number
    K081650
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aerogen (Ireland), Ltd.
    Date Received
    June 12, 2008
    Decision Date
    October 23, 2008
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by Aerogen (Ireland), Ltd.

    K Number Device Name
    K070642 AERONEB PROFESSIONAL NEBULIZER SYSTEM