510(k) K123498 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
BP652N (HEM-6300-Z)
| Applicant | Omron Healthcare, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Mar 21, 2013 |
| Received | Nov 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123498
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.