FDA 510(k)

LiPPS 分析儀，LiPPS 線壓導引針

K 號：K201720 · 2021-02-18

申請人Beijing Bywave Sensing Medical Technology Co., Ltd.

決定日期2021-02-18

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Bywave Sensing Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K201720. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LiPPS Analyzer, LiPPS Wire Pressure Guide Wire?

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is Beijing Bywave Sensing Medical Technology Co., Ltd.. The 510(k) number is K201720.

When did LiPPS Analyzer, LiPPS Wire Pressure Guide Wire receive FDA 510(k) clearance?

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire received FDA 510(k) clearance on 2021-02-18, under 510(k) number K201720.

Who is the listed applicant for LiPPS Analyzer, LiPPS Wire Pressure Guide Wire?

The FDA 510(k) record lists Beijing Bywave Sensing Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LiPPS Analyzer, LiPPS Wire Pressure Guide Wire?

The FDA product code for LiPPS Analyzer, LiPPS Wire Pressure Guide Wire is DQX.

相關器械（代碼：DQX）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：DQX）

官方來源