FDA 510(k)

海龍智能 ECMO 模組

K 號：K191935 · 2020-04-09

決定日期2020-04-09

產品代碼BYS

諮詢委員會履歷

決定相當於

器材摘要

Nautilus Smart ECMO Module is the device name listed in this FDA 510(k) record. The listed applicant is Mc3 Incorporated. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K191935. 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 Smart ECMO Module?

Nautilus Smart ECMO Module is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Mc3 Incorporated. The 510(k) number is K191935.

When did Nautilus Smart ECMO Module receive FDA 510(k) clearance?

Nautilus Smart ECMO Module received FDA 510(k) clearance on 2020-04-09, under 510(k) number K191935.

Who is the listed applicant for Nautilus Smart ECMO Module?

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

What is the FDA product code for Nautilus Smart ECMO Module?

The FDA product code for Nautilus Smart ECMO Module is BYS.

其他以 Mc3 Incorporated 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。

K182914MC3 靜脈通路套件 21030 K180151MC3 頸內雙腔導管 K171610MC3 快流雙腔導管

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。

K232767海龍VF ECMO 氧合器Mc3, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。