FDA 510(k)

mAXIS 鼓膜植入體、mLOOP 鼓膜植入體、mZAM 鼓膜植入體及 mFIX 鼓膜植入體

K 號：K241142 · 2025-01-17

申請人MED-EL Elektromedizinische Geräte GmbH

決定日期2025-01-17

產品代碼ETB

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is MED-EL Elektromedizinische Geräte GmbH. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K241142. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis?

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is MED-EL Elektromedizinische Geräte GmbH. The 510(k) number is K241142.

When did mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis receive FDA 510(k) clearance?

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis received FDA 510(k) clearance on 2025-01-17, under 510(k) number K241142.

Who is the listed applicant for mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis?

The FDA 510(k) record lists MED-EL Elektromedizinische Geräte GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis?

The FDA product code for mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis is ETB.

其他以 MED-EL Elektromedizinische Geräte GmbH 為申請人之記錄

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相關器械（代碼：ETB）

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。

官方來源

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