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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
Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville,  PA  15146
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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