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FDA 510(k)

The C100 Contactless Breathing Monitor

K-Number: K200445 · 2020-06-24

ApplicantCircadia Technologies, Ltd.
Decision Date2020-06-24
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

The C100 Contactless Breathing Monitor 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 2020-06-24 under 510(k) number K200445. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The C100 Contactless Breathing Monitor?

The C100 Contactless Breathing Monitor is a medical device that received FDA 510(k) clearance on 2020-06-24. The listed applicant is Circadia Technologies, Ltd.. The 510(k) number is K200445.

When did The C100 Contactless Breathing Monitor receive FDA 510(k) clearance?

The C100 Contactless Breathing Monitor received FDA 510(k) clearance on 2020-06-24, under 510(k) number K200445.

Who is the listed applicant for The C100 Contactless Breathing Monitor?

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 C100 Contactless Breathing Monitor?

The FDA product code for The C100 Contactless Breathing Monitor is BZQ.

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.

K234003The Circadia C200 System

Related Devices (Code: BZQ)

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.

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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.

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