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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
Original Applicant
RESPIRONICS, INC.
365 plum industrial court
pittsburgh,  PA  15239
Original Contact michelle brinker
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/02/2012
Decision Date 07/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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