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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 K093416
Device Name TRILOGY 200 VENTILATOR
Original Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville,  PA  15146
Original Contact zita yurko
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/02/2009
Decision Date 01/29/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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