K252676
- 510(k) number
- K252676
- Device name
- The Circadia C300 System (C300)
- Applicant
- Circadia Health, Inc. CA · US
- Product code
- DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alar
- Decision date
- 2026-02-03
- Date received
- 2025-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252676.pdf
Official FDA record: K252676
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.