FDA 510(k)

UreTron 多探針碎石系統

K 號：K160198 · 2016-02-23

決定日期2016-02-23

產品代碼FFK

諮詢委員會GU

決定相當於

器材摘要

UreTron MultiProbe Lithotripter System is the device name listed in this FDA 510(k) record. The listed applicant is Med-Sonics Corp.. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K160198. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UreTron MultiProbe Lithotripter System?

UreTron MultiProbe Lithotripter System is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Med-Sonics Corp.. The 510(k) number is K160198.

When did UreTron MultiProbe Lithotripter System receive FDA 510(k) clearance?

UreTron MultiProbe Lithotripter System received FDA 510(k) clearance on 2016-02-23, under 510(k) number K160198.

Who is the listed applicant for UreTron MultiProbe Lithotripter System?

The FDA 510(k) record lists Med-Sonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UreTron MultiProbe Lithotripter System?

The FDA product code for UreTron MultiProbe Lithotripter System is FFK.

其他以 Med-Sonics Corp. 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。

K162119UreTron PF系列探針

相關器械（代碼：FFK）

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。

K243032EHL探針（SCDG-AS）；EHL探針（SCDG-BS）；EHL探針（SCDG-CS）Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K242888電氣水力碎石機（TCS-B3-II）Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K230488EL27-Compact；无菌EHL-ProbesWalz Elektronik GmbH K202813URO-TOUCH 9 法國探針Northgate Technologies, Inc.K191124瑞士立體碎石三合一系統E.M.S Electro Medical Systems S.A K162119UreTron PF系列探針Med-Sonics Corp.

官方來源

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