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FDA 510(k)

CO2 Mainstream Sensor

K-Number: K221118 · 2023-04-05

Decision Date2023-04-05
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CO2 Mainstream Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K221118. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2 Mainstream Sensor?

CO2 Mainstream Sensor is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K221118.

When did CO2 Mainstream Sensor receive FDA 510(k) clearance?

CO2 Mainstream Sensor received FDA 510(k) clearance on 2023-04-05, under 510(k) number K221118.

Who is the listed applicant for CO2 Mainstream Sensor?

The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Mainstream Sensor?

The FDA product code for CO2 Mainstream Sensor is CCK.

Other records listing Draegerwerk AG & CO Kgaa 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.

View all 7 devices →

Related Devices (Code: CCK)

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.

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.