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FDA 510(k)

領鋒指尖脈搏血氧計（無線），領鋒指尖脈搏血氧計（無線）

K 號：K210032 · 2021-09-01

申請人Leadtek Research, Inc.
決定日期2021-09-01
產品代碼DQA
諮詢委員會履歷
決定相當於

器材摘要

Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) is the device name listed in this FDA 510(k) record. The listed applicant is Leadtek Research, Inc.. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K210032. 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 Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)?

Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Leadtek Research, Inc.. The 510(k) number is K210032.

When did Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) receive FDA 510(k) clearance?

Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) received FDA 510(k) clearance on 2021-09-01, under 510(k) number K210032.

Who is the listed applicant for Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)?

The FDA 510(k) record lists Leadtek Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)?

The FDA product code for Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) is DQA.

相關臨床試驗

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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其他以 Leadtek Research, Inc. 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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官方來源

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