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510(k) Data Aggregation

    K Number
    K150137
    Device Name
    SpiroThor
    Manufacturer
    Date Cleared
    2015-05-27

    (125 days)

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

    Cohero Health LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SpiroThor spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical, and hospital settings.
    Device Description
    The Cohero Health SpiroThor Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The proposed device consists of a compact main unit and an ultrasonic flowmeter sensor used with a pulmonary function filter. The device uses an ultrasonic sensor that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.
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