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510(k) Data Aggregation
K Number
K961894Device Name
MDI TUTOR
Manufacturer
MDI TUTOR, INC.
Date Cleared
1996-08-14
(90 days)
Product Code
CCQ
Regulation Number
868.5640Why 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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