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Nihon Kohden CO2 Sensor Kit, Model TG-970P

FDA 510(k)

Class II (US FDA 510(k))

510(k) K083456

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K083456 FDA 510(k)
FDA Product Code
CCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1400 FDA 510(k)
Regulation Number
868.1400 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nihon Kohden CO2 Sensor Kit, Model TG-970P is a medical device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. It is comprised of three main components: a CO2 sensor (photo detector and light emitter) with cable and connector, a CO2 adapter, and an airway adapter.

The device is supplied as a kit and is used in medical settings for monitoring ventilatory status. It received FDA 510(k) clearance (K083456) and is classified under product code CCK. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or additional authorizations is provided in the data.

Frequently asked questions

What is the Nihon Kohden CO2 Sensor Kit, Model TG-970P used for?

The device is intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. This helps clinicians assess how effectively a patient is exchanging gases during respiratory support.

What components are included in the Nihon Kohden CO2 Sensor Kit, Model TG-970P?

The kit consists of three main components: a CO2 sensor (which includes a photo detector and light emitter) with an attached cable and connector, a CO2 adapter, and an airway adapter. These parts work together to enable CO2 monitoring in clinical settings.

How was the Nihon Kohden CO2 Sensor Kit, Model TG-970P cleared for market release?

The device received FDA 510(k) clearance under submission number K083456, indicating it was found substantially equivalent to a legally marketed predicate device. It is classified under product code CCK and was reviewed by the Anesthesiology advisory committee.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P (K083456) — FDA 510 (k ..., TG-970P CO2 Sensor Kit (K161860) — FDA 510 (k) | Innolitics, NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P - fda.report, PDF Nihon Kohden America, Inc. 510(k)jNotification k IZ Revised May 3, 2013 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA 510(k) K083456 24 fields · synced Sep 25, 2026