510(k) K131382 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
| Applicant | Invivo Corporation, Orlando FL, US |
| Decision | Substantially Equivalent, Jul 15, 2013 |
| Received | May 14, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131382
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2020 | Philips North America, LLC Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs Terminated |
MWI | None listed |
| Jun 18, 2020 | Philips North America, LLC Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for Terminated |
MWI | None listed |
| Jan 13, 2015 | Invivo Corporation Philips Expression MR200 MRI Patient Monitoring System. Terminated |
MWI | None listed |
| Oct 15, 2014 | Invivo Corporation Philips Expression MR200 MRI Patient Monitoring System Terminated |
MWI | None listed |
| Oct 1, 2014 | Invivo Corporation Philips Expression MR200 MRI Patient Monitoring System Model 866120 Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.