FDA 510(k)

鼻道擴張系統

K 號：K181838 · 2018-12-20

決定日期2018-12-20

產品代碼LRC

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

Sinusway Dilation System is the device name listed in this FDA 510(k) record. The listed applicant is 3nt Medical , Ltd.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K181838. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sinusway Dilation System?

Sinusway Dilation System is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is 3nt Medical , Ltd.. The 510(k) number is K181838.

When did Sinusway Dilation System receive FDA 510(k) clearance?

Sinusway Dilation System received FDA 510(k) clearance on 2018-12-20, under 510(k) number K181838.

Who is the listed applicant for Sinusway Dilation System?

The FDA 510(k) record lists 3nt Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sinusway Dilation System?

The FDA product code for Sinusway Dilation System is LRC.

其他以 3nt Medical , Ltd. 為申請人之記錄

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相關器械（代碼：LRC）

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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官方來源

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