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PDT — Burn Resuscitation Decision Support Software Class II

FDA Device Classification

Classification Details

Product Code
PDT
Device Class
Class II
Regulation Number
868.1890
Submission Type
Review Panel
SU
Medical Specialty
Anesthesiology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K140387surgeon general, department of the armyBurn Resuscitation Decision Support System - Clinical (BRDSS-C)December 23, 2014
K121659arcosBURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)April 18, 2013