FDA 510(k)

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire

Número K: K201720 · 2021-02-18

RequerenteBeijing Bywave Sensing Medical Technology Co., Ltd.

Data da decisão2021-02-18

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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