510(k) K153739 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MRI Patient Monitor TeslaDUO
| Applicant | Mipm Mammendorfer Institut Fur Physik Und Medizin, Mammendorf, DE |
| Decision | Substantially Equivalent, Jun 28, 2016 |
| Received | Dec 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153739
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.