510(k) K251670 ยท DPS Electrocardiograph
MAC 7 Resting ECG Analysis System
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jan 26, 2026 |
| Received | May 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251670
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.