Nihon Kohden TG-901T CO2 Sensor Kit With Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990063 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 TG-901T CO2 Sensor Kit is a gaseous-phase carbon dioxide gas analyzer. It is designed to measure the concentration of carbon dioxide in a gas mixture to assist in determining a patient's ventilatory status.
This device is identified by FDA 510(k) number K990063 and is classified under product code CCK. It is regulated as a Class II medical device within the anesthesiology specialty.
Frequently asked questions
What is the primary function of the Nihon Kohden TG-901T CO2 Sensor Kit?
This device functions as a gaseous-phase carbon dioxide gas analyzer. Its primary purpose is to measure the concentration of carbon dioxide within a gas mixture, which assists clinicians in determining a patient's ventilatory status.
How is the TG-901T CO2 Sensor Kit classified for regulatory purposes?
The device is regulated as a Class II medical device within the anesthesiology specialty. It is identified under FDA 510(k) number K990063 and is categorized under product code CCK.
What does the TG-901T kit include?
The kit is supplied as the Nihon Kohden TG-901T CO2 sensor along with the necessary accessories required for its operation as a gas analyzer.
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 Tg-901t Co2 Sensor Kit With Accessories, NIHON KOHDEN TG-901T CO2 SENSOR KIT WIT... (K990063) - FDA 510(k), NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990063 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden America, Inc.
Sources (1)
- FDA 510(k) K990063 24 fields · synced Sep 27, 2026