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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 K083526
Device Name TRILOGY 100 VENTILATOR
Original Applicant
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1740 golden mile hwy
monroeville,  PA  15146
Original Contact zita a yurko
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/28/2008
Decision Date 03/13/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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