510(k) K103646 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INTELLIVUE MX40 PATIENT MONITOR
| Applicant | Phillips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Jan 7, 2011 |
| Received | Dec 14, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103646
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2014 | Philips Medical Systems, Inc. IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.