510(k) K180126 ยท OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
SOZO
| Applicant | ImpediMed Limited, Pinkenba, AU |
| Decision | Substantially Equivalent, Apr 16, 2018 |
| Received | Jan 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180126
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2023 | Impedimed Limited SOZO Bilateral Arm L-Dex Software Open, Classified |
OBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.