510(k) K253152 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
| Applicant | Biozen, LLC, Oklahoma City OK, US |
| Decision | Substantially Equivalent, May 6, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253152
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.