510(k) K190693 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
HEM-6410T-ZL Wrist Blood Pressure Monitor
| Applicant | Omron Healthcare, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Apr 17, 2019 |
| Received | Mar 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190693
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.