SOZO is an AI-enabled medical device from ImpediMed Limited, listed by FDA (510(k), K180126) with a decision date of 2018-04-16. Review panel: Cardiovascular.
| FDA submission number | K180126 |
|---|---|
| Pathway | 510(k) |
| Company | ImpediMed Limited |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2018-04-16 |
| Decision | Substantially Equivalent |
| Product code | OBH |
| Classification | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Device class | 2 |
| Regulation number | 870.2770 |
| Review time (calendar days) | 90 |
| Applicant country | AU |
Official FDA database record · FDA AI-enabled device list
More devices from ImpediMed Limited · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.