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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 K181166
Device Name Trilogy Evo
Respironics Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Applicant Contact Colleen Witt
Respironics Inc.
1740 Golden Mile Highway
Monroeville,  PA  15146
Correspondent Contact Colleen Witt
Regulation Number868.5895
Classification Product Code
Subsequent Product Code
Date Received05/02/2018
Decision Date 07/18/2019
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