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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 K053168
Device Name BIPAP FOCUS
Applicant
Respironics (Ireland) Limited
Parkmore Business Park,
Parkmore W.
Galway,  IE
Applicant Contact JOHN O'DEA
Correspondent
Respironics (Ireland) Limited
Parkmore Business Park,
Parkmore W.
Galway,  IE
Correspondent Contact JOHN O'DEA
Regulation Number868.5895
Classification Product Code
MNS  
Date Received11/14/2005
Decision Date 01/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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