FDA 510(k)

EHL探針（SCDG-AS）；EHL探針（SCDG-BS）；EHL探針（SCDG-CS）

K 號：K243032 · 2025-03-21

申請人Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

決定日期2025-03-21

產品代碼FFK

諮詢委員會GU

決定相當於

器材摘要

EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K243032. 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 EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)?

EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K243032.

When did EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) receive FDA 510(k) clearance?

EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) received FDA 510(k) clearance on 2025-03-21, under 510(k) number K243032.

Who is the listed applicant for EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)?

The FDA 510(k) record lists Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)?

The FDA product code for EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) is FFK.

其他以 Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. 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。

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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。

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.K160198UreTron 多探針碎石系統Med-Sonics Corp.

官方來源

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