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510(k) Data Aggregation

    K Number
    K022276
    Device Name
    KOKOMATE
    Manufacturer
    FERRARIS RESPIRATORY, INC.
    Date Cleared
    2002-10-04

    (81 days)

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

    FERRARIS RESPIRATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KoKoMate is a diagnostic spirometer for use in the primary-care setting to measure and report the following spirometric values: Peak Expiratory Flow (PEF), One-Second (FEV1) and Six-Second (FEV6) Forced Expiratory Volumes, Forced Expiratory Flow averaged from 25 - 75% of total volume (FEF25-75%), and the ratio of FEV1/FEV6.
    Device Description
    KoKoMate is a hand-held, self-contained spirometer with disposable mouthpiece designed specifically to measure a few simple expiratory spirometry values in the primary-care setting for diagnostic and screening purposes. The meter features a 4-line by 16-character LCD display; four control buttons; a port to accept its mouthpiece/flow-tube; and an IR data-transfer port. The device measures expiratory breath flow through its mouthpiece, which is designed for single use. For a maximal expiratory effort, the meter determines peak expiratory flow (PEF), one-second forced expiratory volume (FEV1), six-second forced expiratory volume (FEV6), and average forced expiratory flow from 25 - 75% of total volume (FEF25-75%). It reports these values plus the ratio of FEV1/FEV6 and an indication of how these values compare to recognized predicted values. In addition, the meter processes the signals from each expiratory maneuver to help determine the quality of the maneuver to aid the clinician or patient in determining whether the reported values are valid. Along with the spirometer, the KoKoMate system can include one of two optional accessory products. These accessories act as data transfer conduits transferring data streams across optic and serial interfaces as they cradle the meter. One cradle is designed to couple the meter to a PC for data storage, printout, or analysis; the other links the meter directly to a printer for direct printout of a simple spirometry report.
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