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FDA Product Code

FDA Product Code QIJ — Clearance Directory

Device Class
Class II
21 CFR Citation
876.1050

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN180062 EchoTip Insight Portosystemic Pressure Gradient Measuring System Cook Ireland, Ltd. 2019-11-20 Direct —

Product code QIJ · Class II · Gastroenterology, Urology. Data: openFDA.