510(k) K093802 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
ULTRAVIEW DM3 MONITOR
| Applicant | Zoe Medical, Inc., Topsfield MA, US |
| Decision | Substantially Equivalent, Apr 9, 2010 |
| Received | Dec 11, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093802
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2024 | Zoe Medical Incorporated Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330 Open, Classified |
DQA | None listed |
| Sep 14, 2012 | Zoe Medical Incorporated Spacelabs Ultraview DM3 Monitor
Model Number: 91330-NT
The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is int Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.