FDA 510(k)

海龍VF ECMO 氧合器

K 號：K232767 · 2023-10-04

決定日期2023-10-04

產品代碼BYS

諮詢委員會履歷

決定相當於

器材摘要

Nautilus VF ECMO Oxygenator is the device name listed in this FDA 510(k) record. The listed applicant is Mc3, Inc.. It received FDA 510(k) clearance on 2023-10-04 under 510(k) number K232767. The device is classified under product code BYS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nautilus VF ECMO Oxygenator?

Nautilus VF ECMO Oxygenator is a medical device that received FDA 510(k) clearance on 2023-10-04. The listed applicant is Mc3, Inc.. The 510(k) number is K232767.

When did Nautilus VF ECMO Oxygenator receive FDA 510(k) clearance?

Nautilus VF ECMO Oxygenator received FDA 510(k) clearance on 2023-10-04, under 510(k) number K232767.

Who is the listed applicant for Nautilus VF ECMO Oxygenator?

The FDA 510(k) record lists Mc3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nautilus VF ECMO Oxygenator?

The FDA product code for Nautilus VF ECMO Oxygenator is BYS.

其他以 Mc3, 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。

K203409MC3新月形雙腔靜脈內針管

相關器械（代碼：BYS）

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。

K191935海龍智能 ECMO 模組Mc3 Incorporated

官方來源

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