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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, minimal ventilatory support,facility use
510(K) Number K121623
Device Name BIPAP A 40 VENTILATORY SUPPORT SYSTEM
Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville,  PA  15146
Contact elaine larkin
Regulation Number868.5895
Classification Product Code
MNT  
Date Received06/01/2012
Decision Date 12/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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