510(k) K082633 ยท DSI Detector And Alarm, Arrhythmia
INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
| Applicant | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Boeblingen, Baden-Wuerttemberg, DE |
| Decision | Substantially Equivalent, Oct 3, 2008 |
| Received | Sep 10, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082633
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Philips North America Llc Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pedi Terminated |
DSI | None listed |
| Sep 29, 2010 | Philips Healthcare Inc. Philips M3002A IntelliVue X2
Model: 865039
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, rec Terminated |
DSI | None listed |
| Jan 13, 2009 | Philips Medical Systems Philips M8000-64100 Table Mount
Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30.
Pro Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.