510(k) K254058 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DistaSense(TM) (v1)
| Applicant | Life Detection Technologies, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 25, 2026 |
| Received | Dec 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254058
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.