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FDA 510(k)

INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A

K-Number: K053204 · 2006-02-03

ApplicantDraeger Medical AG & Co. Kgaa
Decision Date2006-02-03
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical AG & Co. Kgaa. It received FDA 510(k) clearance on 2006-02-03 under 510(k) number K053204. 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 INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A?

INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Draeger Medical AG & Co. Kgaa. The 510(k) number is K053204.

When did INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A receive FDA 510(k) clearance?

INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A received FDA 510(k) clearance on 2006-02-03, under 510(k) number K053204.

Who is the listed applicant for INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A?

The FDA 510(k) record lists Draeger Medical AG & Co. Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A?

The FDA product code for INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A is CCK.

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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

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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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