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510(k) Data Aggregation

    K Number
    K160253
    Device Name
    Vitalograph Model 6300 micro
    Manufacturer
    VITALOGRAPH (IRELAND) LTD.
    Date Cleared
    2016-08-26

    (207 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALOGRAPH (IRELAND) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld spirometer designed for lung function for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.
    Device Description
    Vitalograph Model 6300 micro is a handheld portable spirometer for performing Spirometry testing to aid in measuring the effect of lung disease on pulmonary function. The device may be used in hospital, healthcare facilities and homes under the supervision of a healthcare provider. The intended use of the 6300 micro is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. The proposed device consists of a main body which incorporates an LCD, a touch panel, pressure transducer and flow circuitry as well as a detachable flow head. The device is used with a pulmonary function filter. Reports may be printed using the USB cable provided. Principles of Operation: The Vitalograph micro measures a subject's lung ventilation by using a flowhead containing a Fleisch Pneumotachograph capable of giving linear signals throughout the entire physiological range. During testing, the airflow through the flowhead produces a pressure differential. Internally this pressure is applied to a pressure transducer, which produces an electric signal. This signal is converted into digital form so that the unit can perform calculations and display the results. Primary functions are: - Interaction will be via the touch screen interface. - The model 6300 Compact performs spirometric measurements using the established fleisch Pneumotachograph, using single breath and multiple-breath testing techniques, to display and record lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) and their sub-divisions to aid in the measuring the effect of lung disease on pulmonary function - Record subject demographic data. - Produce printed reports to external printers.
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