510(k) K252978 ยท DQK Computer, Diagnostic, Programmable
ScioCardio ECG Analysis Platform
| Applicant | Synergen Technology Labs, LLC, Dallas TX, US |
| Decision | Substantially Equivalent, Jul 9, 2026 |
| Received | Sep 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252978
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.