FMS, Finapres Medical Systems BV
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2150-2012 | Class II | Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure | July 6, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K023723 | FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 | October 23, 2003 |
| K023338 | PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 | May 9, 2003 |