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510(k) Data Aggregation

    K Number
    K961894
    Device Name
    MDI TUTOR
    Manufacturer
    MDI TUTOR, INC.
    Date Cleared
    1996-08-14

    (90 days)

    Product Code
    CCQ
    Regulation Number
    868.5640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDI TUTOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDI Tutor is intended for use as an accessory to metered dose inhalers (MDIs) to assist the user by monitoring the inhalation cycle and providing positive feedback (an auditory whistle) to corroborate correct inspiratory technique.
    Device Description
    The device is a simple plastic cylinder designed to fit flush over the mouthpieces of inhalers supplied by Schering (Proventil and Vanceril), Allen and Hanburys (Ventolin and Serevent), and Warrick (Albuterol). A whistle mechanism on the device is activated by the user during inspiration. The accessory device does not introduce additional space to the metered dose inhaler or interfere with the performance of the inhaler. The whistle reminds the user to sustain a slow continuous inspiration when using the metered dose inhaler.
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