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FDA 510(k)

END TIDAL CO2 NASAL CANNULA

K-Number: K120518 · 2012-05-04

ApplicantCare Fusion
Decision Date2012-05-04
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

END TIDAL CO2 NASAL CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2012-05-04 under 510(k) number K120518. 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 END TIDAL CO2 NASAL CANNULA?

END TIDAL CO2 NASAL CANNULA is a medical device that received FDA 510(k) clearance on 2012-05-04. The listed applicant is Care Fusion. The 510(k) number is K120518.

When did END TIDAL CO2 NASAL CANNULA receive FDA 510(k) clearance?

END TIDAL CO2 NASAL CANNULA received FDA 510(k) clearance on 2012-05-04, under 510(k) number K120518.

Who is the listed applicant for END TIDAL CO2 NASAL CANNULA?

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

What is the FDA product code for END TIDAL CO2 NASAL CANNULA?

The FDA product code for END TIDAL CO2 NASAL CANNULA 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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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