510(k) K182127 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Wrist Blood Pressure Monitor Model BP6100
| Applicant | Omron Healthcare, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | Aug 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182127
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.