LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is an AI-enabled medical device from Medtronic, Inc., listed by FDA (510(k), K210484) with a decision date of 2021-06-11. Review panel: Cardiovascular.
| FDA submission number | K210484 |
|---|---|
| Pathway | 510(k) |
| Company | Medtronic, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2021-06-11 |
| Decision | Substantially Equivalent |
| Product code | MXD |
| Classification | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) |
| Device class | 2 |
| Regulation number | 870.1025 |
| Review time (calendar days) | 112 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.