PDT · Class II · 21 CFR 868.1890

FDA Product Code PDT: Burn Resuscitation Decision Support Software

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.

Leading manufacturers include Arcos, Inc. and The Surgeon General, Department of the Army.

2
Total
2
Cleared
315d
Avg days
2013
Since

FDA 510(k) Cleared Burn Resuscitation Decision Support Software Devices (Product Code PDT)

2 devices
1–2 of 2
Cleared Dec 23, 2014
Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
K140387
The Surgeon General, Department of the Army
General & Plastic Surgery · 312d
Cleared Apr 18, 2013
BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
K121659
Arcos, Inc.
General & Plastic Surgery · 317d

About Product Code PDT - Regulatory Context