FDA 510(k)

瑞士立體碎石三合一系統

K 號：K181364 · 2018-06-20

決定日期2018-06-20

產品代碼FEO

諮詢委員會GU

決定相當於

器材摘要

Swiss LithoClast Trilogy is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2018-06-20 under 510(k) number K181364. The device is classified under product code FEO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Swiss LithoClast Trilogy?

Swiss LithoClast Trilogy is a medical device that received FDA 510(k) clearance on 2018-06-20. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K181364.

When did Swiss LithoClast Trilogy receive FDA 510(k) clearance?

Swiss LithoClast Trilogy received FDA 510(k) clearance on 2018-06-20, under 510(k) number K181364.

Who is the listed applicant for Swiss LithoClast Trilogy?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Swiss LithoClast Trilogy?

The FDA product code for Swiss LithoClast Trilogy is FEO.

其他以 E.M.S Electro Medical Systems S.A 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。

K253254GBT機器空氣流預防主機 K243279DOLORCLAST 集中衝擊波 K230893瑞士LthoClast三部曲 K220538DolorClast 體外震波治療器 K190124EMS空氣流預防主機，EMS空氣流一 K191079皮茲頓內置套件，皮茲頓內置套件LED

查看所有 14 項裝置 →

相關器械（代碼：FEO）

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。

K230893瑞士LthoClast三部曲E.M.S Electro Medical Systems S.A K182490瑞士立體碎石三合一系統E.M.S Electro Medical Systems S.A K181997瑞士立體碎石三合一系統E.M.S Electro Medical Systems S.A K173234瑞士立體碎石三合一系統E.M.S Electro Medical Systems S.A K171024震擊脉冲-SE 輸石擊碎系統Cybersonics, 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。