PDT
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Burn Resuscitation Decision Support Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Burn Resuscitation Decision Support System - Clinical (BRDSS-C) (K140387) | The Surgeon General, Department of the Army | 2014-12-23 |
| BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) (K121659) | Arcos, Inc. | 2013-04-18 |
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