510(k) K201865 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Biomonitor III, Biomonitor IIIm
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Dec 8, 2020 |
| Received | Jul 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201865
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.