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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 K101129
Device Name ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
Applicant
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Applicant Contact ZITA A YURKO
Correspondent
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Correspondent Contact ZITA A YURKO
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/22/2010
Decision Date 09/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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