Name: Predicase
Price: 199 USD

K-number	K201720
Device name	LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
Applicant	Beijing Bywave Sensing Medical Technology Co., Ltd.
Product code	DQX
Device class	Class II
Decision date	Feb 18, 2021
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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LiPPS Analyzer, LiPPS Wire Pressure Guide Wire

Everything you need for a 510(k) submission. Nothing you don't.