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FDA 510(k)

Broncoflex Agile;產品參考:20030001,Broncoflex Vortex;產品參考:10030001,Screeni;產品參考:30030001

K 號:K202180 · 2020-10-22

決定日期2020-10-22
產品代碼EOQ
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

Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 is the device name listed in this FDA 510(k) record. The listed applicant is Axess Vision Technology. It received FDA 510(k) clearance on 2020-10-22 under 510(k) number K202180. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001?

Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 is a medical device that received FDA 510(k) clearance on 2020-10-22. The listed applicant is Axess Vision Technology. The 510(k) number is K202180.

When did Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 receive FDA 510(k) clearance?

Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 received FDA 510(k) clearance on 2020-10-22, under 510(k) number K202180.

Who is the listed applicant for Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001?

The FDA 510(k) record lists Axess Vision Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001?

The FDA product code for Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 is EOQ.

相關臨床試驗

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其他以 Axess Vision Technology 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。

相關器械(代碼:EOQ)

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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