510(k) K124061 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MRI PATIENT MONITORING SYSTEM (MODEL 865214)
| Applicant | Invivo Corporation, Orlando FL, US |
| Decision | Substantially Equivalent, Feb 22, 2013 |
| Received | Dec 31, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K124061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2015 | Philips Electronics North America Corporation Invivo Expression MRI Patient Monitoring System. Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.