510(k) K180903 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
3880 MRI Patient Monitoring System
| Applicant | Iradimed Corporation, Winter Springs FL, US |
| Decision | Substantially Equivalent, Mar 29, 2019 |
| Received | Apr 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180903
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.