510(k) K210608 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
LUX-Dx Insertable Cardiac Monitor
| Applicant | Boston Scientific Corporation, St Paul MN, US |
| Decision | Substantially Equivalent, May 25, 2021 |
| Received | Mar 1, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210608
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.