510(k) K182166 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Wrist Blood Pressure Monitor Model BP4350
| Applicant | Omron Healthcare, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Nov 8, 2018 |
| Received | Aug 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182166
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.