510(k) K153557 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
ABPM 7100, Hypertension Management Software
| Applicant | I.E.M. GmbH, Stolberg, DE |
| Decision | Substantially Equivalent, Jul 19, 2016 |
| Received | Dec 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153557
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.