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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, therapeutic (incentive)
510(k) Number K183108
Device Name Combined Aerobika OPEP and VersaPAP device
Trudell Medical International
725 Baransway Drive
London,  CA n5V 5G4
Applicant Contact Marianne Tanton
Trudell Medical International
725 Third Street
London,  CA n5V 5G4
Correspondent Contact Paul Dryden
Regulation Number868.5690
Classification Product Code
Date Received11/08/2018
Decision Date 08/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No