510(k) K190548 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
BIOMONITOR III, Remote Assistant III
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Jul 5, 2019 |
| Received | Mar 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190548
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.