FDA 510(k)

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

K 號：K211223 · 2021-07-21

決定日期2021-07-21

產品代碼OTN

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K211223. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Boston Scientific Corporation. The 510(k) number is K211223.

When did Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System receive FDA 510(k) clearance?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System received FDA 510(k) clearance on 2021-07-21, under 510(k) number K211223.

Who is the listed applicant for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

The FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is OTN.

其他以 Boston Scientific Corporation 為申請人之記錄

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相關器械（代碼：OTN）

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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