FDA 510(k)

EasiSlush

K 號：K191006 · 2019-09-24

決定日期2019-09-24

產品代碼KDN

諮詢委員會GU

決定相當於

器材摘要

EasiSlush is the device name listed in this FDA 510(k) record. The listed applicant is Bridge TO Life, Ltd.. It received FDA 510(k) clearance on 2019-09-24 under 510(k) number K191006. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EasiSlush?

EasiSlush is a medical device that received FDA 510(k) clearance on 2019-09-24. The listed applicant is Bridge TO Life, Ltd.. The 510(k) number is K191006.

When did EasiSlush receive FDA 510(k) clearance?

EasiSlush received FDA 510(k) clearance on 2019-09-24, under 510(k) number K191006.

Who is the listed applicant for EasiSlush?

The FDA 510(k) record lists Bridge TO Life, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasiSlush?

The FDA product code for EasiSlush is KDN.

其他以 Bridge TO Life, Ltd. 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。

K241239器官保護HTK溶液 K203262器官灌流針管

相關器械（代碼：KDN）

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。

K261644Perfadex PlusXvivo Perfusion AB K260456VI°Port™ 肝臟保存系統Traferox Technologies, Inc.K254305BAROguard 腎臟捐贈保存系統Paragonix Technologies, Inc.K243618EasiSlush® 食鹽溶液，用於無菌冰沙製備 (BTLE-1250)Bridge TO Life K243870X°Port 肺部保存系統；X°Port 肺部保存解決方案Traferox Technologies, Inc.K243998DCX一次性卡式碟 (DCX)Institut Geroges Lopez

官方來源

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