FDA 510(k)

馬西莫 Stork

K 號：K223721 · 2023-12-15

決定日期2023-12-15

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Masimo Stork is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K223721. 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 Stork?

Masimo Stork is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Masimo Corporation. The 510(k) number is K223721.

When did Masimo Stork receive FDA 510(k) clearance?

Masimo Stork received FDA 510(k) clearance on 2023-12-15, under 510(k) number K223721.

Who is the listed applicant for Masimo Stork?

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 Stork?

The FDA product code for Masimo Stork is DQA.

其他以 Masimo Corporation 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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