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    K Number
    K100928
    Device Name
    MICRO DIARY SPIROMETER
    Manufacturer
    VIASYS RESPIRATORY CARE INC.
    Date Cleared
    2011-03-07

    (336 days)

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

    VIASYS RESPIRATORY CARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro Diary Spirometer is used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. Specifically, the Micro Diary Spirometer measures the following lung function parameters: FEV1, FVC, FEV6 and PEF. The device also records the test data for later review and has the ability to transfer these test records to a compatible computer.
    Device Description
    The Micro Diary Spirometer is a compact, hand held, and battery operated recording spirometer. The device features a five button keypad and an LCD display. The device utilizes a digital volume transducer. As a patient's exhaled breath is passed through the transducer, the vane rotates. The number of rotations is proportional to the volume of air passed through the transducer, and the frequency of rotation is proportional to the flow rate.
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