510(k) K090556 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
| Applicant | Spacelabs Healthcare Medical Equipment (Suzhou) CO, Nederland CO, US |
| Decision | Substantially Equivalent, Apr 30, 2009 |
| Received | Mar 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2009 | Spacelabs Healthcare, Incorporated Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.