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510(k) Data Aggregation

    K Number
    K082878
    Device Name
    NEVONI CLASSIC, MODEL 6600-PO
    Date Cleared
    2008-12-30

    (92 days)

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

    NSR COMERCIO E REPRESENTACOES LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nevoni Classic 6600-PO nebulizer is an ac powered portable compressor. This portable device uses a pneumatic piston that compresses uir, forcing it to flow into the nebulizer cup. The force of the air flowing into the nebulizer cup disperses the medicine into fine mist particles for the inhalation treatment based on a physician's prescription. This device is intended for single patient home therapy.
    Device Description
    The Nevoni Classic nebulizer is a portable AC-powered respiratory device used for home therapy. It uses a compressor to process medicine into a breathable aerosolized mist which is collected into a facial mask and inhaled by the patient. The device's nebulization process is achieved through a small wired AC-electric motor that forces an oil-free piston into motion. This motion oscillates a sealed diaphragm and compresses air into a small chamber. Air intake is supplied to the compressor using a felt filter. The compressed air flow is conducted through a thin flexible tube into a nebulizer cup in which a fine particle mist is created by the medicine's highly pressurized contact. The nebulizer cup is attached to an anatomical mask made of soft, non-toxic material. The medicine's mist accumulates within this mask where it is ready for inhalation by the patient. The Nevoni Classic nebulizer package includes a compressor, air tubing, air filters and adult and child size masks.
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