FDA 510(k)

Servator M 輔助解決方案

K 號：K211842 · 2021-12-20

決定日期2021-12-20

產品代碼KDL

諮詢委員會GU

決定相當於

器材摘要

Servator M SALF Solution is the device name listed in this FDA 510(k) record. The listed applicant is S.A.L.F. Spa. It received FDA 510(k) clearance on 2021-12-20 under 510(k) number K211842. 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 Servator M SALF Solution?

Servator M SALF Solution is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is S.A.L.F. Spa. The 510(k) number is K211842.

When did Servator M SALF Solution receive FDA 510(k) clearance?

Servator M SALF Solution received FDA 510(k) clearance on 2021-12-20, under 510(k) number K211842.

Who is the listed applicant for Servator M SALF Solution?

The FDA 510(k) record lists S.A.L.F. Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Servator M SALF Solution?

The FDA product code for Servator M SALF Solution is KDL.

其他以 S.A.L.F. Spa 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。

K230193Servator P Plus 輔助治療溶液 K202652Servator P 輔助治療溶液含THAM K190063Servator C 輔助溶液 K180481Servator B 輔助溶液 K170150Servator H SALF 溶液-1000 ml PVC 免袋，Servator H SALF 溶液-2000 ml PVC 免袋

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 K221387BEL-GEN 冷藏解決方案Institut Georges Lopez 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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