LiPPS Analyzer, LiPPS Wire Pressure Guide Wire

Wire, Guide, Catheter

Beijing Bywave Sensing Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Beijing Bywave Sensing Medical Technology Co., Ltd. with the FDA for Lipps Analyzer, Lipps Wire Pressure Guide Wire.

Pre-market Notification Details

Device IDK201720
510k NumberK201720
Device Name:LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
ClassificationWire, Guide, Catheter
Applicant Beijing Bywave Sensing Medical Technology Co., Ltd. Room 501, Buildinctg 22, No.12, Juyuan Middle Road, Mapo Town, Shunyi District Beijing,  CN 101399
ContactLizhe Zhang
CorrespondentLizhe Zhang
Beijing Bywave Sensing Medical Technology Co., Ltd. Room 501, Buildinctg 22, No.12, Juyuan Middle Road, Mapo Town, Shunyi District Beijing,  CN 101399
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-23
Decision Date2021-02-18

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