510(k) K050233 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI
| Applicant | Omron Healthcare, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Oct 28, 2005 |
| Received | Feb 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050233
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.