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FDA 510(k)

Endure ETCO2/02 Nasal Cannula

K-Number: K213767 · 2023-09-12

ApplicantEndure Industries, Inc.
Decision Date2023-09-12
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Endure ETCO2/02 Nasal Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Endure Industries, Inc.. It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K213767. 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 Endure ETCO2/02 Nasal Cannula?

Endure ETCO2/02 Nasal Cannula is a medical device that received FDA 510(k) clearance on 2023-09-12. The listed applicant is Endure Industries, Inc.. The 510(k) number is K213767.

When did Endure ETCO2/02 Nasal Cannula receive FDA 510(k) clearance?

Endure ETCO2/02 Nasal Cannula received FDA 510(k) clearance on 2023-09-12, under 510(k) number K213767.

Who is the listed applicant for Endure ETCO2/02 Nasal Cannula?

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

What is the FDA product code for Endure ETCO2/02 Nasal Cannula?

The FDA product code for Endure ETCO2/02 Nasal Cannula is CCK.

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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