510(k) K170628 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
BioMonitor 2-AF, BioMonitor 2-S
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Mar 31, 2017 |
| Received | Mar 2, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170628
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.