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FDA 510(k)

CO2 Mainstream Sensor

K-Number: K221118 · 2023-04-05

ApplicantDraegerwerk AG & CO Kgaa
Decision Date2023-04-05
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CO2 Mainstream Sensor is a medical device manufactured by Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2023-04-05 under approval 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. It is manufactured by Draegerwerk AG & CO Kgaa. The 510(k) number is K221118.

When was CO2 Mainstream Sensor approved by the FDA?

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

What company makes CO2 Mainstream Sensor?

CO2 Mainstream Sensor is manufactured by Draegerwerk AG & CO Kgaa.

What is the FDA product code for CO2 Mainstream Sensor?

The FDA product code for CO2 Mainstream Sensor is CCK.

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Related Devices (Code: CCK)

K162343Westmed Gas Sampling Cannula with O2 deliveryWestmed, Inc. K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH K171765Nihon Kohden CO2 MonitorNihon Kohden Corporation K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesGE Healthcare Finland Oy K161250OC-FLEX Flexible IntraOral CannulaVenture Therapeutics, Inc.

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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