510(k) K253463 ยท DQK Computer, Diagnostic, Programmable
ILR ECG Analyzer (IM007)
| Applicant | Implicity, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Jul 2, 2026 |
| Received | Oct 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253463
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.