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FDA 510(k)

心電血氧濃度計

K 號:K211400 · 2022-02-11

決定日期2022-02-11
產品代碼DQA
諮詢委員會履歷
決定相當於

器材摘要

Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K211400. 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?

Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. The 510(k) number is K211400.

When did Pulse Oximeter receive FDA 510(k) clearance?

Pulse Oximeter received FDA 510(k) clearance on 2022-02-11, under 510(k) number K211400.

Who is the listed applicant for Pulse Oximeter?

The FDA 510(k) record lists Beijing Choice Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulse Oximeter?

The FDA product code for Pulse Oximeter is DQA.

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其他以 Beijing Choice Electronic Technology Co., Ltd. 為申請人之記錄

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相關器械(代碼:DQA)

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官方來源

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