510(k) K150310 ยท DSI Detector And Alarm, Arrhythmia
IntelliVue Patient Monitor
| Applicant | Philips Medizin Systeme Boeblingen GmbH, Boeblingen, DE |
| Decision | Substantially Equivalent, May 13, 2015 |
| Received | Feb 9, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150310
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2025 | Philips North America Llc IntelliVue MP2. Product Number: M8102A. Open, Classified |
DSI | None listed |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP5. Product Number: M8105A. Open, Classified |
DSI | None listed |
| Dec 2, 2025 | Philips North America Llc IntelliVue Multi Measurement Server X2. Product Number: M3002A. Open, Classified |
DSI | None listed |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX600. Product Number: 865242. Open, Classified |
DSI | None listed |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX700. Product Number: 865241. Open, Classified |
DSI | None listed |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX800. Product Number: 865240. Open, Classified |
DSI | None listed |
| Jun 30, 2020 | Philips North America, LLC IntelliVue MX800 patient monitor, model no. 865240 Terminated |
MHX | None listed |
| Jun 30, 2020 | Philips North America, LLC IntelliVue MX700 patient monitor, model no. 865241 Terminated |
MHX | None listed |
| Aug 23, 2017 | Philips Electronics North America Corporation IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5
Product Usage:
Indicated for use Open, Classified |
MHX | None listed |
| Jan 4, 2016 | Philips Electronics North America Corporation Philips IntelliVue Measurement Module X1
Model: M3001A Terminated |
MHX | None listed |
| Jan 4, 2016 | Philips Electronics North America Corporation Philips IntelliVue Module Measurement X2
Model: M3002A Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.