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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K093905
Device Name TRILOGY 202 VENTILATOR
Applicant
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Applicant Contact JOSEPH OLSAVSKY
Correspondent
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Correspondent Contact JOSEPH OLSAVSKY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/22/2009
Decision Date 05/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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