K234003
- 510(k) number
- K234003
- Device name
- The Circadia C200 System
- Applicant
- Circadia Technologies, Ltd. GB
- Product code
- DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alar
- Decision date
- 2024-05-30
- Date received
- 2023-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K234003.pdf
Official FDA record: K234003
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.