The following data is part of a premarket notification filed by Arcos, Inc. with the FDA for Burn Resuscitation Decision Support System (brdss).
| Device ID | K121659 |
| 510k Number | K121659 |
| Device Name: | BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) |
| Classification | Burn Resuscitation Decision Support Software |
| Applicant | ARCOS, INC. 866 W. 41ST Houston, TX 77018 |
| Contact | Chris Meador |
| Correspondent | Chris Meador ARCOS, INC. 866 W. 41ST Houston, TX 77018 |
| Product Code | PDT |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-05 |
| Decision Date | 2013-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B2551143 | K121659 | 000 |
| B2551125 | K121659 | 000 |
| B2551120 | K121659 | 000 |