510(k) K140387
- Device
- Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
- Applicant
- THE SURGEON GENERAL, DEPARTMENT OF THE ARMY
- 510(k) number
- K140387
- Product code
- PDT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-12-23
- Date received
- 2014-02-14
- Regulation
- 868.1890
- Classification name
- Burn Resuscitation Decision Support Software
- Medical specialty
- Anesthesiology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH A BERTRAM, MD, PHD
- Address
- 1430 Veterans Dr. Fort Detrick MD US 21702 21702
Source Documents#
Other 510(k) Records For Product Code PDT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121659 | BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) | Arcos, Inc. | 2013-04-18 |
Legacy Summary#
summary
FDA Review#
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