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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
Original Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville,  PA  15146
Original Contact joseph olsavsky
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/29/2009
Decision Date 05/12/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
statement statement
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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