Cleared Traditional

The Circadia C200 System

K234003 · Circadia Technologies, Ltd. · Cardiovascular

May 2024

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K234003 is an FDA 510(k) clearance for the The Circadia C200 System, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Circadia Technologies, Ltd. (London, GB). The FDA issued a Cleared decision on May 30, 2024, 163 days after receiving the submission on December 19, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K234003 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2023
Decision Date	May 30, 2024
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF