510(k) K031124 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
| Applicant | Datex-Ohmeda, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Dec 4, 2003 |
| Received | Apr 8, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2011 | Spacelabs Healthcare, Llc The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's vent Terminated |
MHX | None listed |
| Feb 16, 2006 | Spacelabs Medical Incorporated Ultraview SL Capnography Module, Model 91517
A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ven Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.