510(k) K081654 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
HEM-9000AI
| Applicant | Omron Healthcare, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Oct 10, 2008 |
| Received | Jun 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081654
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.