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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 K173918
Device Name VersaPAP Positive Airway Pressure (PAP) Device
Applicant
Trudell Medical International
725 Third Street
London,  CA n5V 5G4
Applicant Contact Marianne Tanton
Correspondent
Trudell Medical International
725 Third Street
London,  CA n5V 5G4
Correspondent Contact Marianne Tanton
Regulation Number868.5690
Classification Product Code
BWF  
Date Received12/22/2017
Decision Date 08/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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