Viterion TeleHealthcare Llc
FDA Regulatory Profile
Viterion TeleHealthcare Llc appears in FDA public data with 3 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0820-2013, Class II) was initiated on November 15, 2012. Its most recent 510(k) clearance was granted on November 6, 2003.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0820-2013 | Class II | Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Phys | November 15, 2012 |
| Z-0821-2013 | Class II | Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological pati | November 15, 2012 |
| Z-0822-2013 | Class II | Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physi | November 15, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K030419 | VITERION 100 TELEHEALTH MONITOR | November 6, 2003 |