ImpediMed Limited
FDA 510(k) & PMA Approved Devices — 13 products
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Total Devices13
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | DSB | 2026-08-17 | View |
| 510(k) | K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | OBH | 2026-01-28 | View |
| 510(k) | K232089 | SOZO Pro | DSB | 2023-10-17 | View |
| 510(k) | K230531 | SOZO Pro | QJB | 2023-05-04 | View |
| 510(k) | K230530 | SOZO Pro | OBH | 2023-05-04 | View |
| 510(k) | K203473 | SOZO | DSB | 2021-04-19 | View |
| 510(k) | K193410 | SOZO Body Fluid Analyzer | DSB | 2020-10-02 | View |
| 510(k) | K190529 | SOZO | QJB | 2019-11-25 | View |
| 510(k) | K180126 | SOZO | OBH | 2018-04-16 | View |
| 510(k) | K172507 | SOZO | DSB | 2017-12-22 | View |
| 510(k) | K172122 | SOZO | OBH | 2017-08-11 | View |
| 510(k) | K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | OBH | 2013-05-31 | View |
| 510(k) | K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | OBH | 2011-11-04 | View |
No matching devices.
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