Pinkenba, AU · 6 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DSB | — | — | — | 3 | 2023-10-17 |
| OBH | — | — | — | 2 | 2026-01-28 |
| QJB | Adjunct Monitor, Protein Calorie Malnutrition | Class II | Cardiovascular | 1 | 2023-05-04 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-08-17 | Class II | Ongoing | Z-0155-2024 | SOZO Bilateral Arm L-Dex Software | — | Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment,… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-28 | K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | OBH | — | — |
| 2023-10-17 | K232089 | SOZO Pro | DSB | — | — |
| 2023-05-04 | K230531 | SOZO Pro | QJB | Class II | Cardiovascular |
| 2023-05-04 | K230530 | SOZO Pro | OBH | — | — |
| 2021-04-19 | K203473 | SOZO | DSB | — | — |
| 2020-10-02 | K193410 | SOZO Body Fluid Analyzer | DSB | — | — |