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510(k) K121659

BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) by Arcos, Inc. — Product Code PDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2013
Date Received
June 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burn Resuscitation Decision Support Software
Device Class
Class II
Regulation Number
868.1890
Review Panel
SU
Submission Type

The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.

Other clearances for product code PDT

  • K140387 — Burn Resuscitation Decision Support System - Clinical (BRDSS-C) (December 23, 2014)