510(k) K082045 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
| Applicant | Spacelabs Medical, Inc., Las Vegas NV, US |
| Decision | Substantially Equivalent, Aug 1, 2008 |
| Received | Jul 18, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082045
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2011 | Spacelabs Healthcare, Incorporated The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display.
The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resisti Terminated |
MHZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.