510(k) K172200 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, Oct 25, 2017 |
| Received | Jul 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172200
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.