FDA 510(k)

Balex骨擴張系統

K 號：K202027 · 2021-02-03

決定日期2021-02-03

產品代碼HRX

諮詢委員會或

決定相當於

器材摘要

Balex bone Expander System is the device name listed in this FDA 510(k) record. The listed applicant is Taeyeon Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-02-03 under 510(k) number K202027. 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 Balex bone Expander System?

Balex bone Expander System is a medical device that received FDA 510(k) clearance on 2021-02-03. The listed applicant is Taeyeon Medical Co., Ltd.. The 510(k) number is K202027.

When did Balex bone Expander System receive FDA 510(k) clearance?

Balex bone Expander System received FDA 510(k) clearance on 2021-02-03, under 510(k) number K202027.

Who is the listed applicant for Balex bone Expander System?

The FDA 510(k) record lists Taeyeon Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Balex bone Expander System?

The FDA product code for Balex bone Expander System is HRX.

其他以 Taeyeon Medical 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。

K212700Dyflex-II

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)

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。