510(k) K223630 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Apr 5, 2023 |
| Received | Dec 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223630
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.