510(k) K163045 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Omron HEM-6400T-Z Wrist Blood Pressure Monitor
| Applicant | Omron Healthcare, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Feb 21, 2017 |
| Received | Oct 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163045
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.