BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
FDA 510(k) clearance K121659 · decided 2013-04-18
Clearance details
- K-number
- K121659
- Device name
- BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
- Applicant
- Arcos, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-05
- Decision date
- 2013-04-18
- Days to decision
- 317 days
- Clearance type
- Traditional
- Product code
- PDT
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Burn Resuscitation Decision Support System - Clinical (BRDSS-C) (K140387) | The Surgeon General, Department of the Army | 2014-12-23 |
Recalls involving this device
No recalls on record reference this clearance.