FDA 510(k)

SpO2 延長線

K 號：K222370 · 2023-04-02

申請人Beijing Rongrui-Century Science & Technology Co., Ltd.

決定日期2023-04-02

產品代碼DSA

諮詢委員會履歷

決定相當於

器材摘要

SpO2 Extension Cable is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Rongrui-Century Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-02 under 510(k) number K222370. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SpO2 Extension Cable?

SpO2 Extension Cable is a medical device that received FDA 510(k) clearance on 2023-04-02. The listed applicant is Beijing Rongrui-Century Science & Technology Co., Ltd.. The 510(k) number is K222370.

When did SpO2 Extension Cable receive FDA 510(k) clearance?

SpO2 Extension Cable received FDA 510(k) clearance on 2023-04-02, under 510(k) number K222370.

Who is the listed applicant for SpO2 Extension Cable?

The FDA 510(k) record lists Beijing Rongrui-Century Science & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpO2 Extension Cable?

The FDA product code for SpO2 Extension Cable is DSA.

其他以 Beijing Rongrui-Century Science & Technology Co., Ltd. 為申請人之記錄

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K242986SpO2 延長線

相關器械（代碼：DSA）

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。

官方來源

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