510(k) K171801 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
| Applicant | Philips Medizin Systeme Boeblingen GmbH, Boeblingen, DE |
| Decision | Substantially Equivalent, Oct 6, 2017 |
| Received | Jun 16, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K171801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2025 | Philips North America Llc IntelliVue Multi-Measurement Module X3. Product Number: 867030. Open, Classified |
DSI | None listed |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX100. Product Number: 867033. Open, Classified |
DSI | None listed |
| Apr 6, 2018 | Philips Electronics North America Corporation IntelliVue X3 Patient Monitor. Terminated |
MHX | None listed |
| Mar 3, 2018 | Philips Electronics North America Corporation Philips Network Firewall (Cisco ASA 5506), Model # 867098 Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.