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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 K113053
Device Name BIPAP A 30 VENTILATORY SUPPORT SYSTEM
Applicant
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Applicant Contact ELAINE LARKIN
Correspondent
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Correspondent Contact ELAINE LARKIN
Regulation Number868.5895
Classification Product Code
MNS  
Date Received10/13/2011
Decision Date 02/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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