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FDA 510(k)

TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

K-Number: K243956 · 2025-06-10

ApplicantNihon Kohden Corporation
Decision Date2025-06-10
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) is a medical device manufactured by Nihon Kohden Corporation. It received FDA 510(k) clearance on 2025-06-10 under approval number K243956. 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 TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)?

TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) is a medical device that received FDA 510(k) clearance on 2025-06-10. It is manufactured by Nihon Kohden Corporation. The 510(k) number is K243956.

When was TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) approved by the FDA?

TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) received FDA 510(k) clearance on 2025-06-10, under approval number K243956.

What company makes TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)?

TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) is manufactured by Nihon Kohden Corporation.

What is the FDA product code for TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)?

The FDA product code for TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) is CCK.

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Related Devices (Code: CCK)

K162343Westmed Gas Sampling Cannula with O2 deliveryWestmed, Inc. K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH K171765Nihon Kohden CO2 MonitorNihon Kohden Corporation K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesGE Healthcare Finland Oy K161250OC-FLEX Flexible IntraOral CannulaVenture Therapeutics, 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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