FDA 510(k)

TG-980P 二氧化碳感測器套件（TG-980P）；TG-980P1 二氧化碳感測器套件（TG-980P1）

K 號：K243956 · 2025-06-10

決定日期2025-06-10

產品代碼CCK

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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) 記錄中將 Nihon Kohden Corporation 列為申請人。這並不單獨確立設備製造商的身份。

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.

其他以 Nihon Kohden Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：CCK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251641GF-310R 多氣體單元（GF-310R）Nihon Kohden Corporation K261633視覺呼吸Affirm Medical Technologies II, LLC K253030Capnostream™35 輕便呼吸監測器 (PM35MN)Covidien, LLC K250148醫療氣體分析儀（AG200）Prior Care Science Technology, Ltd.K2512160184 CO2 標本採集管；0184T CO2 標本採集管；0139 CO2 標本採集管；0182 CO2 標本採集管Barbaras Development, Inc.K240937AIM (N/A)Inventeur, LLC

官方來源

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