FDA 510(k)

Carescape SpO2 - Masimo

K 號：K212876 · 2021-10-08

決定日期2021-10-08

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Carescape SpO2 - Masimo is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K212876. 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 Carescape SpO2 - Masimo?

Carescape SpO2 - Masimo is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Masimo Corporation. The 510(k) number is K212876.

When did Carescape SpO2 - Masimo receive FDA 510(k) clearance?

Carescape SpO2 - Masimo received FDA 510(k) clearance on 2021-10-08, under 510(k) number K212876.

Who is the listed applicant for Carescape SpO2 - Masimo?

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 Carescape SpO2 - Masimo?

The FDA product code for Carescape SpO2 - Masimo 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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