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FDA 510(k)

CARESCAPE CO2 Microstream parameter

K-Number: K213518 · 2022-04-12

ApplicantCovidien, LLC
Decision Date2022-04-12
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CARESCAPE CO2 Microstream parameter is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2022-04-12 under approval number K213518. 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 CARESCAPE CO2 Microstream parameter?

CARESCAPE CO2 Microstream parameter is a medical device that received FDA 510(k) clearance on 2022-04-12. It is manufactured by Covidien, LLC. The 510(k) number is K213518.

When was CARESCAPE CO2 Microstream parameter approved by the FDA?

CARESCAPE CO2 Microstream parameter received FDA 510(k) clearance on 2022-04-12, under approval number K213518.

What company makes CARESCAPE CO2 Microstream parameter?

CARESCAPE CO2 Microstream parameter is manufactured by Covidien, LLC.

What is the FDA product code for CARESCAPE CO2 Microstream parameter?

The FDA product code for CARESCAPE CO2 Microstream parameter 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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