510(k) K001671 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
| Applicant | Omron Healthcare, Inc., Vernon Hills IL, US |
| Decision | Substantially Equivalent, Jun 30, 2000 |
| Received | Jun 1, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001671
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.