FDA 510(k)

MightySat -OTC

K 號：K214115 · 2024-01-31

決定日期2024-01-31

產品代碼OLK

諮詢委員會履歷

決定相當於

器材摘要

MightySat -OTC is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2024-01-31 under 510(k) number K214115. The device is classified under product code OLK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MightySat -OTC?

MightySat -OTC is a medical device that received FDA 510(k) clearance on 2024-01-31. The listed applicant is Masimo Corporation. The 510(k) number is K214115.

When did MightySat -OTC receive FDA 510(k) clearance?

MightySat -OTC received FDA 510(k) clearance on 2024-01-31, under 510(k) number K214115.

Who is the listed applicant for MightySat -OTC?

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 MightySat -OTC?

The FDA product code for MightySat -OTC is OLK.

其他以 Masimo Corporation 為申請人之記錄

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相關器械（代碼：OLK）

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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