FDA 510(k)

馬斯醫療 Masimo CARESCAPE SpO2 – 馬斯醫療搭配SpHb

K 號：K221953 · 2022-08-04

決定日期2022-08-04

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Masimo CARESCAPE SpO2 – Masimo with SpHb is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2022-08-04 under 510(k) number K221953. 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 Masimo CARESCAPE SpO2 – Masimo with SpHb?

Masimo CARESCAPE SpO2 – Masimo with SpHb is a medical device that received FDA 510(k) clearance on 2022-08-04. The listed applicant is Masimo Corporation. The 510(k) number is K221953.

When did Masimo CARESCAPE SpO2 – Masimo with SpHb receive FDA 510(k) clearance?

Masimo CARESCAPE SpO2 – Masimo with SpHb received FDA 510(k) clearance on 2022-08-04, under 510(k) number K221953.

Who is the listed applicant for Masimo CARESCAPE SpO2 – Masimo with SpHb?

FDA 510(k) 記錄中將 Masimo Corporation 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Masimo CARESCAPE SpO2 – Masimo with SpHb?

The FDA product code for Masimo CARESCAPE SpO2 – Masimo with SpHb is DQA.

其他以 Masimo Corporation 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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