510(k) K254226 ยท DQK Computer, Diagnostic, Programmable
PulseAPI SmartWatch
| Applicant | PulseAI, Ltd., Belfast, GB |
| Decision | Substantially Equivalent, Oct 27, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254226
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.