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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 K113743
Device Name EVOLUTION 3E VENTILATOR
Original Applicant
EVENT MEDICAL, INC.
971 calle amanecer
suite 101
san clemente,  CA  92673
Original Contact rick waters
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/20/2011
Decision Date 12/18/2012
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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