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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percussor, Powered-Electric
510(k) Number K051383
Device Name THE INCOURAGE SYSTEM
Applicant
Respiratory Technologies, Incorporated
8095 215 St. W.
Lakeville,  MN  55044
Applicant Contact MARIO NOZZARELLA
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number868.5665
Classification Product Code
BYI  
Date Received05/27/2005
Decision Date 06/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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