The following data is part of a premarket notification filed by The Surgeon General, Department Of The Army with the FDA for Burn Resuscitation Decision Support System - Clinical (brdss-c).
| Device ID | K140387 |
| 510k Number | K140387 |
| Device Name: | Burn Resuscitation Decision Support System - Clinical (BRDSS-C) |
| Classification | Burn Resuscitation Decision Support Software |
| Applicant | THE SURGEON GENERAL, DEPARTMENT OF THE ARMY 1430 VETERANS DRIVE Fort Detrick, MD 21702 |
| Contact | Kenneth A Bertram, Md, Phd |
| Correspondent | Kenneth A Bertram, Md, Phd THE SURGEON GENERAL, DEPARTMENT OF THE ARMY 1430 VETERANS DRIVE Fort Detrick, MD 21702 |
| Product Code | PDT |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-12-23 |
| Summary: | summary |