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FDA 510(k)

MGA-IR SIDESTREAM PCO2 MODULE

K-Number: K904863 · 1991-06-19

ApplicantMarquette Gas Analysis Corp.
Decision Date1991-06-19
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MGA-IR SIDESTREAM PCO2 MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Gas Analysis Corp.. It received FDA 510(k) clearance on 1991-06-19 under 510(k) number K904863. 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 MGA-IR SIDESTREAM PCO2 MODULE?

MGA-IR SIDESTREAM PCO2 MODULE is a medical device that received FDA 510(k) clearance on 1991-06-19. The listed applicant is Marquette Gas Analysis Corp.. The 510(k) number is K904863.

When did MGA-IR SIDESTREAM PCO2 MODULE receive FDA 510(k) clearance?

MGA-IR SIDESTREAM PCO2 MODULE received FDA 510(k) clearance on 1991-06-19, under 510(k) number K904863.

Who is the listed applicant for MGA-IR SIDESTREAM PCO2 MODULE?

The FDA 510(k) record lists Marquette Gas Analysis Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MGA-IR SIDESTREAM PCO2 MODULE?

The FDA product code for MGA-IR SIDESTREAM PCO2 MODULE is CCK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Marquette Gas Analysis Corp. 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.

K893589MULTI-GAS ANALYZER (MGA)

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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