PDT — Burn Resuscitation Decision Support Software Class II
FDA product code PDT covers "Burn Resuscitation Decision Support Software", a Class II medical device regulated under 21 CFR 868.1890. Submissions are reviewed by the Anesthesiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PDT
- Device Class
- Class II
- Regulation Number
- 868.1890
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Anesthesiology
- Implant
- No
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.