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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 K122769
Device Name REMSTAR SE
Original Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville,  PA  15146
Original Contact frank kadi
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/11/2012
Decision Date 10/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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