BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)


Device Classification Name

burn resuscitation decision support software

510(k) Number K121659
Device Name BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
Applicant
ARCOS, INC.
866 w. 41st
houston, 
TX 
77018

Applicant Contact chris meador
Correspondent
ARCOS, INC.
866 w. 41st
houston, 
TX 
77018

Correspodent Contact chris meador
Regulation Number 868.1890
Classification Product Code
PDT  
Date Received 06/05/2012
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