510(k) K040012 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
WELL@HOME SYSTEM
| Applicant | Zoe Medical, Inc., Topsfield MA, US |
| Decision | Substantially Equivalent, Apr 2, 2004 |
| Received | Jan 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2010 | Zoe Medical Incorporated The Well@Home Monitor by Patient Care technologies
Model 179-2150
Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.