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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 K123400
Device Name AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
Applicant
TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON,  CA N5V 5G4
Applicant Contact DARRYL FISCHER
Correspondent
TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON,  CA N5V 5G4
Correspondent Contact DARRYL FISCHER
Regulation Number868.5690
Classification Product Code
BWF  
Date Received11/05/2012
Decision Date 05/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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