FDA 510(k)

無限中央站廣域版，無限M300，無限M300+

K 號：K231477 · 2023-10-17

決定日期2023-10-17

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Infinity CentralStation Wide, Infinity M300, Infinity M300+ is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-10-17 under 510(k) number K231477. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Infinity CentralStation Wide, Infinity M300, Infinity M300+?

Infinity CentralStation Wide, Infinity M300, Infinity M300+ is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K231477.

When did Infinity CentralStation Wide, Infinity M300, Infinity M300+ receive FDA 510(k) clearance?

Infinity CentralStation Wide, Infinity M300, Infinity M300+ received FDA 510(k) clearance on 2023-10-17, under 510(k) number K231477.

Who is the listed applicant for Infinity CentralStation Wide, Infinity M300, Infinity M300+?

FDA 510(k) 記錄將 Draeger Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Infinity CentralStation Wide, Infinity M300, Infinity M300+?

The FDA product code for Infinity CentralStation Wide, Infinity M300, Infinity M300+ is MHX.

其他以 Draeger Medical Systems, 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：MHX）

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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