510(k) K261286 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
The Circadia C300 System (C300)
| Applicant | Circadia Health, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, May 20, 2026 |
| Received | Apr 20, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261286
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.