FDA 510(k)

指尖血氧計

K 號：K202776 · 2021-03-01

申請人Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

決定日期2021-03-01

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Fingertip pulse oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K202776. 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 Fingertip pulse oximeter?

Fingertip pulse oximeter is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. The 510(k) number is K202776.

When did Fingertip pulse oximeter receive FDA 510(k) clearance?

Fingertip pulse oximeter received FDA 510(k) clearance on 2021-03-01, under 510(k) number K202776.

Who is the listed applicant for Fingertip pulse oximeter?

The FDA 510(k) record lists Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fingertip pulse oximeter?

The FDA product code for Fingertip pulse oximeter is DQA.

其他以 Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. 為申請人之記錄

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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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