510(k) K253224 ยท OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
| Applicant | ImpediMed Limited, Pinkenba, AU |
| Decision | Substantially Equivalent, Jan 28, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253224
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.