510(k) K964697 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
| Applicant | Advance Medical Device, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Feb 11, 1997 |
| Received | Nov 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964697
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.