FDA 510(k)

BEL-GEN 冷藏解決方案

K 號：K221387 · 2022-06-14

決定日期2022-06-14

產品代碼KDL

諮詢委員會GU

決定相當於

器材摘要

BEL-GEN Cold Storage Solution 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 2022-06-14 under 510(k) number K221387. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BEL-GEN Cold Storage Solution?

BEL-GEN Cold Storage Solution is a medical device that received FDA 510(k) clearance on 2022-06-14. The listed applicant is Institut Georges Lopez. The 510(k) number is K221387.

When did BEL-GEN Cold Storage Solution receive FDA 510(k) clearance?

BEL-GEN Cold Storage Solution received FDA 510(k) clearance on 2022-06-14, under 510(k) number K221387.

Who is the listed applicant for BEL-GEN Cold Storage Solution?

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 BEL-GEN Cold Storage Solution?

The FDA product code for BEL-GEN Cold Storage Solution is KDL.

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 K211224RM4控制單元

相關器械（代碼：KDL）

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Bridge TO Life, Ltd.K221386PERF-GEN 閃脈灌注解決方案Institut Georges Lopez K211842Servator M 輔助解決方案S.A.L.F. Spa K192408Custodiol HTK 溶液Dr. Franz Kohler Chemie GmbH K170150Servator H SALF 溶液-1000 ml PVC 免袋，Servator H SALF 溶液-2000 ml PVC 免袋S.A.L.F. Spa

官方來源

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