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FDA 510(k)

The Circadia C200 System

K-Number: K234003 · 2024-05-30

ApplicantCircadia Technologies, Ltd.
Decision Date2024-05-30
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The Circadia C200 System is the device name listed in this FDA 510(k) record. The listed applicant is Circadia Technologies, Ltd.. It received FDA 510(k) clearance on 2024-05-30 under 510(k) 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. The listed applicant is Circadia Technologies, Ltd.. The 510(k) number is K234003.

When did The Circadia C200 System receive FDA 510(k) clearance?

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

Who is the listed applicant for The Circadia C200 System?

The FDA 510(k) record lists Circadia Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Circadia Technologies, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200445The C100 Contactless Breathing Monitor

Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.K231733Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies , Ltd.

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.

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