PDT · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1890
Classification
FDA Product Code
PDT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.1890
Review panel
SU
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.