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    K Number
    K102240
    Device Name
    NIVO NEBULIZER SYSTEM
    Manufacturer
    AEROGEN IRELAND, LTD.
    Date Cleared
    2010-11-10

    (93 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEROGEN IRELAND, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance. The NIVO Nebuliser System is suitable for use in adult and pediatric 7 years or older (>20kg) patients whilst using a facemask. The Aeroneb® Pro X control module, cables, adaptor and bracket components of the NIVO Nebuliser system are intended for multiple patient use as described in the instruction manual. The NIVO Nebuliser unit, EE and SE elbow components of the NIVO Nebuliser system are intended for single use as described in the instruction manual.
    Device Description
    The NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance. The system includes the Aeroneb® Pro X control module, cables, adaptor and bracket components (intended for multiple patient use) and the NIVO Nebuliser unit, EE and SE elbow components (intended for single use).
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