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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, positive pressure breathing, intermittent
510(k) Number K121955
Model 1098160
Device Name COUGHASSIST T70 DEVICE
Original Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville,  PA  15146
Original Contact colleen witt
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received07/03/2012
Decision Date 12/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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