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Burn Resuscitation Decision Support Software

FDA product code PDT · 1 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.1890
Review panel
SU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2013-04-18 – 2013-04-18

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.

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