510(k) K132649 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
REVEAL LINQ INSERTABLE CARDIAC MONITOR
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Feb 14, 2014 |
| Received | Aug 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132649
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2016 | Medtronic Inc. Reveal LINQ insertable Cardiac Monitor, Model LNQ11.
Monitors subcutaneous ECG continuously. Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.