The Circadia C200 System— 510(k) K234003

Substantially Equivalent

Circadia Technologies, Ltd.

FDA 510(k) clearance K234003 for The Circadia C200 System, Substantially Equivalent on 2024-05-30. Applicant: Circadia Technologies, Ltd..

Clearance details

Applicant: Circadia Technologies, Ltd.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2023-12-19
Decision date: 2024-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.