510(k) K162855 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Reveal LINQ
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Feb 23, 2017 |
| Received | Oct 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2021 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic Reveal LINQ LNQ11 / PA96000 Open, Classified |
MXD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.