FDA 510(k)

CO2 主流模組

K 號：K192446 · 2020-05-21

申請人Beijing Kingst Commercial & Trade Co., Ltd.

決定日期2020-05-21

產品代碼CCK

諮詢委員會AN

決定相當於

器材摘要

CO2 Mainstream Module is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Kingst Commercial & Trade Co., Ltd.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K192446. 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 CO2 Mainstream Module?

CO2 Mainstream Module is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Beijing Kingst Commercial & Trade Co., Ltd.. The 510(k) number is K192446.

When did CO2 Mainstream Module receive FDA 510(k) clearance?

CO2 Mainstream Module received FDA 510(k) clearance on 2020-05-21, under 510(k) number K192446.

Who is the listed applicant for CO2 Mainstream Module?

The FDA 510(k) record lists Beijing Kingst Commercial & Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Mainstream Module?

The FDA product code for CO2 Mainstream Module is CCK.

其他以 Beijing Kingst Commercial & Trade Co., Ltd. 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。

K192488CO2旁路模組

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。

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官方來源

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