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510(k) Data Aggregation

    K Number
    K072163
    Device Name
    HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
    Date Cleared
    2008-03-06

    (213 days)

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

    3A HEALTH CARE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Happyneb II. Happyneb III. Speedy, Nebby Plus and the Myneb is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. Each of these devices must be used exclusively with their own nebulizer and mouthpiece. The devices Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the home care market, although they may also be used by trained hospital staff personnel as well. The Myneb model is intended to be used only in home health care. The Happyneb II, Happyneb III. Speedy, Nebby Plus and the Myneb are intended for multiple use, are non-sterile and for use with pharmaceutical products which are under physician prescription.
    Device Description
    The family of 3A Health Care nebulizers include 5 different devices: 4 are AC powered devices (Happyneb II, Happyneb III, Speedy, Nebby Plus) and one model (Myneb) with a DC motor, a rechargeable battery pack and an external charger/power supplier. The 4 AC compressors (Happyneb II, Happyneb III, Speedy, and Nebby Plus) have different plastic housings. There are three different types of electrical motors for AC models and one type for the DC model (Myneb). The 5 models of compressors are designed to use two nebulizers, the Fasterjet and Nebjet.
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