Arcos, Inc
FDA Regulatory Profile
Arcos, Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2295-2019, Class II) was initiated on March 16, 2015. Its most recent 510(k) clearance was granted on April 18, 2013.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2295-2019 | Class II | Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Nav | March 16, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K121659 | BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) | April 18, 2013 |