FDA 510(k)

單次使用微電極（銅質，帶金層柱）；單次使用微電極（不銹鋼柱）

K 號：K163442 · 2017-09-28

申請人Modern Medical Equipment Manufacturing Limited

決定日期2017-09-28

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing Limited. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K163442. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)?

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Modern Medical Equipment Manufacturing Limited. The 510(k) number is K163442.

When did Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) receive FDA 510(k) clearance?

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) received FDA 510(k) clearance on 2017-09-28, under 510(k) number K163442.

Who is the listed applicant for Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)?

The FDA 510(k) record lists Modern Medical Equipment Manufacturing Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)?

The FDA product code for Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is GEI.

其他以 Modern Medical Equipment Manufacturing Limited 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。

K170703單次使用關節鏡電極（附筆）K152059一次性通用電極

相關器械（代碼：GEI）

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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