510(k) K152330 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Expression MR400 MRI Patient Monitoring System
| Applicant | Invivo Corporation, Orlando FL, US |
| Decision | Substantially Equivalent, Dec 23, 2015 |
| Received | Aug 18, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2020 | Philips North America, LLC Expression MR400 MRI Patient Monitoring System
Model Number: 866185
Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitor Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.