Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
FDA 510(k) clearance K140387 · decided 2014-12-23
Clearance details
- K-number
- K140387
- Device name
- Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
- Applicant
- The Surgeon General, Department of the Army
- Decision
- Substantially Equivalent
- Date received
- 2014-02-14
- Decision date
- 2014-12-23
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- PDT
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Fort Detrick, MD, 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 (BRDSS) (K121659) | Arcos, Inc. | 2013-04-18 |
Recalls involving this device
No recalls on record reference this clearance.