510(k) K083517 ยท DSI Detector And Alarm, Arrhythmia
INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90
| Applicant | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Boeblingen, Baden-Wuerttemberg, DE |
| Decision | Substantially Equivalent, Jan 16, 2009 |
| Received | Nov 26, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Philips North America Llc Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neo Terminated |
DSI | None listed |
| Sep 29, 2010 | Philips Healthcare Inc. Philips M8102A IntelliVue MP2
Model: 865040
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, re Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.