510(k) K251221 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
| Applicant | Abbott, Sylmar CA, US |
| Decision | Substantially Equivalent, Sep 17, 2025 |
| Received | Apr 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251221
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.