510(k) K193473 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
| Applicant | Boston Scientific Corporation, St Paul MN, US |
| Decision | Substantially Equivalent, Jun 26, 2020 |
| Received | Dec 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193473
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.