FDA 510(k)

ACCLARENT AERA 鼻咽管擴張系統

K 號：K230742 · 2023-12-13

決定日期2023-12-13

產品代碼PNZ

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

ACCLARENT AERA Eustachian Tube Dilation System is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K230742. The device is classified under product code PNZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACCLARENT AERA Eustachian Tube Dilation System?

ACCLARENT AERA Eustachian Tube Dilation System is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Acclarent, Inc.. The 510(k) number is K230742.

When did ACCLARENT AERA Eustachian Tube Dilation System receive FDA 510(k) clearance?

ACCLARENT AERA Eustachian Tube Dilation System received FDA 510(k) clearance on 2023-12-13, under 510(k) number K230742.

Who is the listed applicant for ACCLARENT AERA Eustachian Tube Dilation System?

The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCLARENT AERA Eustachian Tube Dilation System?

The FDA product code for ACCLARENT AERA Eustachian Tube Dilation System is PNZ.

其他以 Acclarent, Inc. 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。

K253612Acclarent AERA 鼻咽管氣球擴張系統 K231862TruDi®導航系統V3 (FG-2000-00)K221037TruDi 剃刀刀片 K201115下一代球囊擴張系統 K201174真迪淨治器 K193453真迪探針

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相關器械（代碼：PNZ）

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。

K253612Acclarent AERA 鼻咽管氣球擴張系統Acclarent, Inc.K223542TubaVent 气球擴張系統Spiggle & Theis Medizintechnik GmbH K230065VenSure™ 機器擴張系統，VenSure™ 輕量機器擴張系統，VenSure™ 導航機器擴張系統，VenSure™ ET 機器擴張系統Fiagon GmbH K220027Audion ET 膨脹系統Entellus Medical, Inc.K210841NuVent 鼓室管擴張氣球Medtronic Xomed, Inc.K171761ACCLARENT AERA 鼻咽管氣球擴張系統Acclarent, Inc.

官方來源

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