510(k) K121659
- Device
- BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
- Applicant
- ARCOS, INC.
- 510(k) number
- K121659
- Product code
- PDT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-04-18
- Date received
- 2012-06-05
- 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
- CHRIS MEADOR
- Address
- 866 W. 41st Houston TX US 77018 77018
Source Documents#
Other 510(k) Records For Product Code PDT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140387 | Burn Resuscitation Decision Support System - Clinical (BRDSS-C) | The Surgeon General, Department of the Army | 2014-12-23 |
Legacy Summary#
summary
FDA Review#
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