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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name burn resuscitation decision support software
510(k) Number K121659
Model H2 AND CF-19
Device Name BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
Original Applicant
ARCOS, INC.
866 w. 41st
houston,  TX  77018
Original Contact chris meador
Regulation Number868.1890
Classification Product Code
PDT  
Date Received06/05/2012
Decision Date 04/18/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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