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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, non-life-supporting
510(k) Number K092818
Device Name BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
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
MNS  
Date Received09/14/2009
Decision Date 01/22/2010
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
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