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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
Applicant
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1740 golden mile hwy
monroeville,  PA  15146
Applicant Contact zita a yurko
Correspondent
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1740 golden mile hwy
monroeville,  PA  15146
Correspondent Contact zita a yurko
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/28/2008
Decision Date 03/13/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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