510(k) K253059 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
| Applicant | Tournicare Pty, Ltd., Balwyn, AU |
| Decision | Substantially Equivalent, Jun 15, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253059
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.