K261286
- 510(k) number
- K261286
- Device name
- The Circadia C300 System (C300)
- Applicant
- Circadia Health, Inc. CA · US
- Product code
- DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alar
- Decision date
- 2026-05-20
- Date received
- 2026-04-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261286.pdf
Official FDA record: K261286
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.