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.

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
No devices found for this product code.

About Product Code PDT - Regulatory Context