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510(k) K140387

Burn Resuscitation Decision Support System - Clinical (BRDSS-C) by The Surgeon General, Department of the Army — Product Code PDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2014
Date Received
February 14, 2014
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 by The Surgeon General, Department of the Army

  • K143592 — GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC (April 16, 2015)

Other clearances for product code PDT

  • K121659 — BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) (April 18, 2013)