FDA 510(k)

迪拉德鼻氣球導管

K 號：K181546 · 2020-01-03

決定日期2020-01-03

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

Dillard Nasal Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Intuit Medical Products, LLC. It received FDA 510(k) clearance on 2020-01-03 under 510(k) number K181546. 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 Dillard Nasal Balloon Catheter?

Dillard Nasal Balloon Catheter is a medical device that received FDA 510(k) clearance on 2020-01-03. The listed applicant is Intuit Medical Products, LLC. The 510(k) number is K181546.

When did Dillard Nasal Balloon Catheter receive FDA 510(k) clearance?

Dillard Nasal Balloon Catheter received FDA 510(k) clearance on 2020-01-03, under 510(k) number K181546.

Who is the listed applicant for Dillard Nasal Balloon Catheter?

The FDA 510(k) record lists Intuit Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dillard Nasal Balloon Catheter?

The FDA product code for Dillard Nasal Balloon Catheter is LRC.

其他以 Intuit Medical Products, LLC 為申請人之記錄

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K153484迪拉德氣道擴張系統

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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