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FDA 510(k)

GF-310R Multigas Unit (GF-310R)

K-Number: K251641 · 2026-08-12

ApplicantNihon Kohden Corporation
Decision Date2026-08-12
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GF-310R Multigas Unit (GF-310R) is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2026-08-12 under 510(k) number K251641. 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 GF-310R Multigas Unit (GF-310R)?

GF-310R Multigas Unit (GF-310R) is a medical device that received FDA 510(k) clearance on 2026-08-12. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K251641.

When did GF-310R Multigas Unit (GF-310R) receive FDA 510(k) clearance?

GF-310R Multigas Unit (GF-310R) received FDA 510(k) clearance on 2026-08-12, under 510(k) number K251641.

Who is the listed applicant for GF-310R Multigas Unit (GF-310R)?

The FDA 510(k) record lists Nihon Kohden Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GF-310R Multigas Unit (GF-310R)?

The FDA product code for GF-310R Multigas Unit (GF-310R) is CCK.

Other records listing Nihon Kohden Corporation as applicant

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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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