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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K091112
Device Name RESPIRONICS SLEEPEASY CPAP SYSTEM
Applicant
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Applicant Contact ZITA A YURKO
Correspondent
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Correspondent Contact ZITA A YURKO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/17/2009
Decision Date 05/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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