510(k) K093501 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
| Applicant | Spacelabs Medical, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Nov 24, 2009 |
| Received | Nov 12, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093501
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2011 | Spacelabs Healthcare, Llc Spacelabs Medical elance Vital Signs Monitor, Model 93300.
The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in Terminated |
MHX | None listed |
| Aug 2, 2011 | Spacelabs Healthcare, Llc Vital Sign elance Monitor, Model 93300
Spacelabs Healthcare, Llc.
A vital signs patient monitor with arrhythmia detection. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.