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510(k) Data Aggregation

    K Number
    K032849
    Device Name
    AERONEB GO NEBULIZER, MODEL AG-AG2000
    Manufacturer
    AEROGEN, INC.
    Date Cleared
    2003-11-21

    (70 days)

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

    AEROGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
    Device Description
    The Aeroneb Go nebulizer uses the OnQ™ Aerosol Generator, which is comprised of a unique dome shaped aperture plate containing over 1,000 precision-formed tapered holes surrounded by a vibrational element. When energy is applied, the aperture plate vibrates approximately 100,000 times per second. This rapid vibration causes each aperture to act as a micropump, drawing liquid through the holes to form consistently sized droplets. The Aeroneb Go nebulizer is lightweight, compact and silent. The device can be powered with the AC Power Controller or with the Battery Powered Controller that uses three "AA" disposable batteries.
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    K Number
    K021175
    Device Name
    AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
    Manufacturer
    AEROGEN, INC.
    Date Cleared
    2002-05-15

    (33 days)

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

    AEROGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation and other positive pressure breathing assistance. The Aeroneb Pro is suitable for use in adult and pediatric patients as described in the Instruction Manual.
    Device Description
    The Aeroneb® Professional Nebulizer System is a multiple patient reusable pulmonary drug delivery system that incorporates Aerogen's proprietary aerosol generator technology for continuous nebulization of drugs to patients. The Aeroneb Pro is designed to be used with mechanical ventilators and pressurized breathing systems as well as by spontaneously breathing patients. It is intended for multiple patient use and is autoclavable. The nebulizer can be placed in the inspiratory limb of a ventilator circuit or used with a mask or mouthpiece. The Aeroneb Pro operates without changing patient ventilatory parameters, can be refilled without interrupting ventilation, and can be powered by AC/DC adapter or internal rechargeable battery. Because the Aeroneb Pro operates without compressed gas and can be battery-powered, it is also suitable for use during patient transport.
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    K Number
    K003022
    Device Name
    AERONEB PORTABLE NEBULIZER
    Manufacturer
    AEROGEN, INC.
    Date Cleared
    2000-10-13

    (15 days)

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

    AEROGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992831
    Device Name
    AERONEB II, MODEL APN 200
    Manufacturer
    AEROGEN, INC.
    Date Cleared
    2000-08-25

    (368 days)

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

    AEROGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AeroNeb™ II Portable Nebulizer is intended for breath-triggered nebulization of aerosolized medications prescribed by a physician.
    Device Description
    The AeroNeb™ II is a battery operated hand-held portable nebulizer using the same materials and piezoelectric vibration aerosol generator technology as the predicate device.
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