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510(k) Data Aggregation

    K Number
    K101348
    Device Name
    AGACHAMBER SPACER
    Date Cleared
    2011-04-29

    (351 days)

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

    AGAPLASTIC IND. COM. LTDA.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AgaChamber Spacer is intended to be used by patients, who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or healthcare professional. The device has been developed for use, with or without mask, in accordance with necessity and medical orientation. The intended environments for use include home, hospitals and clinics.
    Device Description
    AgaChamber Spacer is composed of a conical chamber with openings on both of its sides, where in one of these opening there is an attached base with an orifice into which the medication dose is inserted and the Metered Dose Inhaler dispenses the medication. On the other side, there is a nozzle which holds the mask. which the patient will fit over his/her nose and mouth so that the medication can be inhaled. The device has been developed for use, with or without mask. The percentage of the drug dose delivered into the chamber is totally dependent on the Metered Dose Inhaler's pressure and guantity of metered doses the healthcare provider prescribes. Another point that should be clear is that, AgaChamber is a passive device and its main function is to provide a space extension between the Metered Dose Inhaler and the patient's nose and mouth in order to facilitate the inhalation of the medication. AgaChamber is composed of wrought plastic parts and assembled I together by a process of thermoplastic injection. IMPORTANT NOTE: AGACHAMBER SPACER IS LATEX FREE.
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