FDA 510(k)

心電氧濃度計（FS20P）；心電氧濃度計（FS20C）；心電氧濃度計（FS10C）

K 號：K243049 · 2025-01-02

申請人Hunan Accurate Bio-Medical Technology Co., Ltd.

決定日期2025-01-02

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Accurate Bio-Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-02 under 510(k) number K243049. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)?

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Hunan Accurate Bio-Medical Technology Co., Ltd.. The 510(k) number is K243049.

When did Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) receive FDA 510(k) clearance?

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) received FDA 510(k) clearance on 2025-01-02, under 510(k) number K243049.

Who is the listed applicant for Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)?

The FDA 510(k) record lists Hunan Accurate Bio-Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)?

The FDA product code for Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) is DQA.

其他以 Hunan Accurate Bio-Medical Technology 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。

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相關器械（代碼：DQA）

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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