FDA 510(k)

單次使用關節鏡電極（附筆）

K 號：K170703 · 2018-05-31

申請人Modern Medical Equipment Manufacturing Limited

決定日期2018-05-31

產品代碼HRX

諮詢委員會或

決定相當於

器材摘要

Single Use Arthroscopic Electrode (with Pencil) 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 2018-05-31 under 510(k) number K170703. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Single Use Arthroscopic Electrode (with Pencil)?

Single Use Arthroscopic Electrode (with Pencil) is a medical device that received FDA 510(k) clearance on 2018-05-31. The listed applicant is Modern Medical Equipment Manufacturing Limited. The 510(k) number is K170703.

When did Single Use Arthroscopic Electrode (with Pencil) receive FDA 510(k) clearance?

Single Use Arthroscopic Electrode (with Pencil) received FDA 510(k) clearance on 2018-05-31, under 510(k) number K170703.

Who is the listed applicant for Single Use Arthroscopic Electrode (with Pencil)?

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 Arthroscopic Electrode (with Pencil)?

The FDA product code for Single Use Arthroscopic Electrode (with Pencil) is HRX.

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。

K163442單次使用微電極（銅質，帶金層柱）；單次使用微電極（不銹鋼柱）K152059一次性通用電極

相關器械（代碼：HRX）

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。

K260203富麗椎體成形術氣球針管Beijing Fule Science & Technology Development Co., Ltd.K254103霍普金斯內視鏡術望遠鏡Karl Storz SE & CO. KG K252790數位ClarusScope系統及數位NeuroPEN系統Clarus Medical, LLC K253523Freedom DS™ 解壓系統Spinal Simplicity K252546Vantage™ 腰椎减压套件Allevion Medical, LLC K253217MiiS Horus 鼻喉鏡 (EJA 100)；MiiS Horus 結腸鏡顯示系統 - 平板 (EDS 500)；MiiS Horus 結腸鏡顯示系統 - 遙控盒 (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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