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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 a medical device manufactured by Circadia Technologies, Ltd.. It received FDA 510(k) clearance on 2020-06-24 under approval 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. It is manufactured by Circadia Technologies, Ltd.. The 510(k) number is K200445.

When was The C100 Contactless Breathing Monitor approved by the FDA?

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

What company makes The C100 Contactless Breathing Monitor?

The C100 Contactless Breathing Monitor is manufactured by Circadia Technologies, Ltd..

What is the FDA product code for The C100 Contactless Breathing Monitor?

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

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Other Devices by Circadia Technologies, Ltd.

K234003The Circadia C200 System

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Official Source

View on FDA Database →

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

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