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FDA 510(k)

OXYARM CO2

K-Number: K014211 · 2002-06-11

ApplicantSouthmedic, Inc.
Decision Date2002-06-11
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYARM CO2 is the device name listed in this FDA 510(k) record. The listed applicant is Southmedic, Inc.. It received FDA 510(k) clearance on 2002-06-11 under 510(k) number K014211. 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 OXYARM CO2?

OXYARM CO2 is a medical device that received FDA 510(k) clearance on 2002-06-11. The listed applicant is Southmedic, Inc.. The 510(k) number is K014211.

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

OXYARM CO2 received FDA 510(k) clearance on 2002-06-11, under 510(k) number K014211.

Who is the listed applicant for OXYARM CO2?

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

What is the FDA product code for OXYARM CO2?

The FDA product code for OXYARM CO2 is CCK.

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Other records listing Southmedic, 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.

K222511Oxy2ProK101953SMDIA-1000K945993VAPOFILK923265FUNNEL ADAPTORK863318AEROSOL-TK861839VAPOFIL

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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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