510(k) K122439 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INTELLIVUE PATIENT MONITOR
| Applicant | Philips Medizin Systeme Boeblingen GmbH, Boeblingen, DE |
| Decision | Substantially Equivalent, Aug 29, 2012 |
| Received | Aug 10, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122439
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2025 | Philips North America Llc IntelliVue MP20. Product Number: M8001A. Open, Classified |
DSI | None listed |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP30. Product Number: M8002A. Open, Classified |
DSI | None listed |
| May 4, 2017 | Philips Electronics North America Corporation NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383) Terminated |
MHX | None listed |
| Oct 21, 2014 | Philips Medical Systems, Inc. Philips IntelliVue Monitors with software revisions J.21.03, J.21.19.
Model Product
MP5 M8105A;
MP5SC M8105AS;
MP5T M8105AT;
MP5 Upgrade M8105AU ;
MP5SC Upgrade 866327
The monitors are intend Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.