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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
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 (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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