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510(k) Data Aggregation

    K Number
    K160837
    Device Name
    MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
    Manufacturer
    Date Cleared
    2017-02-23

    (335 days)

    Product Code
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDINET SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MEDINET INCENTIVE SPIROMETER – RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser. MEDINET INCENTIVE SPIROMETER - RESPIPROGRAM is intended for single use in a hospital or home care setting.
    Device Description
    The RESPIPROGRAM is an inspiratory device used as breathing exerciser; RESPIPROGRAM is a FLOW exerciser. The RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser. It is intended for single-patient, single use both in a hospital or for home care therapy. RESPIPROGRAM is a single patient, single use, disposable, non-sterile device. RESPIPROGRAM is a single use device that allows the patient to indicate visually the capacity of inhaling, even though RESPIPROGRAM doesn't have a specific measuring function. The device is a stimulator for inspiration; therefore it is indicated in all situations for when it is necessary to stimulate the patient's inhalation, under the prescription of a physician. The patient inspires through a mouthpiece that is connected to 3 chambers that have 3 balls of different colors (red, yellow and green) each one indicating a different approximate flow rate (respectively 600, 900 and 1200 ml per second).
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