K-number	DEN180062
Device name	EchoTip Insight Portosystemic Pressure Gradient Measuring System
Applicant	Cook Ireland, Ltd.
Product code	QIJ
Device class	Class II
Decision date	Nov 20, 2019
Decision	Not Substantially Equivalent
Regulation	876.1050

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Source

View the full FDA submission: accessdata.fda.gov

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EchoTip Insight Portosystemic Pressure Gradient Measuring System

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