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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, facility use
510(K) Number K120639
Device Name PERFORMAX PEDIATRIC SE TOTAL FACE MASK
Applicant
RESPIRONICS, INC.
365 plum industrial court
pittsburgh,  PA  15239
Contact michelle brinker
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/02/2012
Decision Date 07/10/2012
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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