510(k) K253516 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Assert-IQ (DM5100)
| Applicant | ABBOTT MEDICAL, Sylmar CA, US |
| Decision | Substantially Equivalent, Dec 18, 2025 |
| Received | Nov 12, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253516
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.