FDA 510(k)

TG-980P CO2 传感器套件 (TG-980P); TG-980P1 CO2 传感器套件 (TG-980P1)

K号: K243956 · 2025-06-10

决定日期2025-06-10

产品代码CCK

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决定实质等同

器械摘要

TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) 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 2025-06-10 under 510(k) number K243956. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K243956.

When did TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) receive FDA 510(k) clearance?

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

Who is the listed applicant for TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)?

FDA 510(k)记录中列出Nihon Kohden Corporation为申请人。这本身并不足以确立该设备制造商的身份。

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.

列明Nihon Kohden Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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