PDTClass II
Burn Resuscitation Decision Support Software
Anesthesiology · 21 CFR 868.1890
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.
MDR events0All time
Recalls1All time
Registered firms0Currently listed
510(k) clearances2All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
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Most-reported manufacturers
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Recalls
1 recall events for this product code
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.