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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
Applicant
EVENT MEDICAL, INC.
971 CALLE AMANECER
SUITE 101
SAN CLEMENTE,  CA  92673
Applicant Contact RICK WATERS
Correspondent
EVENT MEDICAL, INC.
971 CALLE AMANECER
SUITE 101
SAN CLEMENTE,  CA  92673
Correspondent Contact RICK WATERS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/20/2011
Decision Date 12/18/2012
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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