510(k) K052154 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
| Applicant | Omron Healthcare, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Sep 8, 2005 |
| Received | Aug 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052154
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.