FDA 510(k)

The Circadia C200 System

K-Number: K234003 · 2024-05-30

Decision Date2024-05-30

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

The Circadia C200 System is a medical device manufactured by Circadia Technologies, Ltd.. It received FDA 510(k) clearance on 2024-05-30 under approval number K234003. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Circadia C200 System?

The Circadia C200 System is a medical device that received FDA 510(k) clearance on 2024-05-30. It is manufactured by Circadia Technologies, Ltd.. The 510(k) number is K234003.

When was The Circadia C200 System approved by the FDA?

The Circadia C200 System received FDA 510(k) clearance on 2024-05-30, under approval number K234003.

What company makes The Circadia C200 System?

The Circadia C200 System is manufactured by Circadia Technologies, Ltd..

What is the FDA product code for The Circadia C200 System?

The FDA product code for The Circadia C200 System is DRT.

Other Devices by Circadia Technologies, Ltd.

K200445The C100 Contactless Breathing Monitor

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.