510(k) K262447 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
The Circadia CX00 System (CX00)
| Applicant | Circadia Health, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Oct 15, 2026 |
| Received | Jul 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262447
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.