510(k) K042505 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
| Applicant | Omron Healthcare, Inc., Vernon Hills IL, US |
| Decision | Substantially Equivalent, Apr 5, 2005 |
| Received | Sep 15, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042505
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.