FDA 510(k)

RM4控制單元

K 號：K211224 · 2021-10-15

決定日期2021-10-15

產品代碼KDN

諮詢委員會GU

決定相當於

器材摘要

RM4 Control Unit is the device name listed in this FDA 510(k) record. The listed applicant is Institut Georges Lopez. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K211224. 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 RM4 Control Unit?

RM4 Control Unit is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Institut Georges Lopez. The 510(k) number is K211224.

When did RM4 Control Unit receive FDA 510(k) clearance?

RM4 Control Unit received FDA 510(k) clearance on 2021-10-15, under 510(k) number K211224.

Who is the listed applicant for RM4 Control Unit?

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

What is the FDA product code for RM4 Control Unit?

The FDA product code for RM4 Control Unit is KDN.

其他以 Institut Georges Lopez 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。

K221386PERF-GEN 閃脈灌注解決方案 K221387BEL-GEN 冷藏解決方案

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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