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FDA 510(k)

CO2 EASY

K-Number: K070128 · 2007-02-15

ApplicantWestmed, Inc.
Decision Date2007-02-15
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CO2 EASY is the device name listed in this FDA 510(k) record. The listed applicant is Westmed, Inc.. It received FDA 510(k) clearance on 2007-02-15 under 510(k) number K070128. 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 CO2 EASY?

CO2 EASY is a medical device that received FDA 510(k) clearance on 2007-02-15. The listed applicant is Westmed, Inc.. The 510(k) number is K070128.

When did CO2 EASY receive FDA 510(k) clearance?

CO2 EASY received FDA 510(k) clearance on 2007-02-15, under 510(k) number K070128.

Who is the listed applicant for CO2 EASY?

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 CO2 EASY?

The FDA product code for CO2 EASY is CCK.

Other records listing Westmed, Inc. as applicant

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.

K162343Westmed Gas Sampling Cannula with O2 deliveryK121382WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]K081905ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMPK072220PEDI CO2 EASYK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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