510(k) K121424 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
EXPRESSION INFORMATION PORTAL
| Applicant | Invivo Corporation, Orlando FL, US |
| Decision | Substantially Equivalent, Jun 13, 2012 |
| Received | May 14, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121424
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2014 | Invivo Corporation Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 Terminated |
MWI | None listed |
| Aug 19, 2014 | Invivo Corporation Philips IP5 Information Portal
The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care pr Terminated |
MWI | None listed |
| Feb 26, 2014 | Invivo Corporation Invivo Corporation Expression IP5 Information Portal
Product Usage:
The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is int Terminated |
MWI | None listed |
| Feb 14, 2014 | Invivo Corporation Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI proced Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.