510(k) K161531 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800
| Applicant | Philips Medizin Systeme Boeblingen GmbH, Boeblingen, DE |
| Decision | Substantially Equivalent, Jul 1, 2016 |
| Received | Jun 2, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2016 | Philips Electronics North America Corporation IntelliVue Patient Monitor
Product Usage:
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.