PDT · Burn Resuscitation Decision Support Software
Anesthesiology · 21 CFR 868.1890 · Class 2
Overview
| Product Code | PDT |
|---|---|
| Device Name | Burn Resuscitation Decision Support Software |
| Regulation | 21 CFR 868.1890 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140387 | Burn Resuscitation Decision Support System - Clinical (BRDSS-C) | The Surgeon General, Department of the Army | Dec 23, 2014 | SESE |
| K121659 | BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) | Arcos, Inc. | Apr 18, 2013 | SESE |
Top Applicants
- Arcos, Inc. — 1 clearance
- The Surgeon General, Department of the Army — 1 clearance
