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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2022-04-12 under 510(k) 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. The listed applicant is Covidien, LLC. The 510(k) number is K213518.

When did CARESCAPE CO2 Microstream parameter receive FDA 510(k) clearance?

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

Who is the listed applicant for CARESCAPE CO2 Microstream parameter?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

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)

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

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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