510(k) K121659
K121659 is an FDA 510(k) premarket notification submitted by Arcos, Inc. for the device "BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)". The FDA issued a decision of Substantially Equivalent on April 18, 2013. The device falls under product code PDT (Burn Resuscitation Decision Support Software), a Class II device regulated under 21 CFR 868.1890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2013
- Date Received
- June 5, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Burn Resuscitation Decision Support Software
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- SU
- Submission Type
The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.