510(k) K251463 · DQK Computer, Diagnostic, Programmable
EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
| Applicant | ABBOTT MEDICAL, St. Paul MN, US |
| Decision | Substantially Equivalent, Sep 4, 2025 |
| Received | May 12, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251463
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.