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FDA 510(k)

Westmed Gas Sampling Cannula with O2 delivery

K-Number: K162343 · 2016-12-14

ApplicantWestmed, Inc.
Decision Date2016-12-14
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Westmed Gas Sampling Cannula with O2 delivery is the device name listed in this FDA 510(k) record. The listed applicant is Westmed, Inc.. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K162343. 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 Westmed Gas Sampling Cannula with O2 delivery?

Westmed Gas Sampling Cannula with O2 delivery is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Westmed, Inc.. The 510(k) number is K162343.

When did Westmed Gas Sampling Cannula with O2 delivery receive FDA 510(k) clearance?

Westmed Gas Sampling Cannula with O2 delivery received FDA 510(k) clearance on 2016-12-14, under 510(k) number K162343.

Who is the listed applicant for Westmed Gas Sampling Cannula with O2 delivery?

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

What is the FDA product code for Westmed Gas Sampling Cannula with O2 delivery?

The FDA product code for Westmed Gas Sampling Cannula with O2 delivery is CCK.

Related Clinical Trials

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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.

K261633VisuBreathAffirm 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.K240937AIM (N/A)Inventeur, LLC

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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