FDA 510(k), K202145, Bigfoot Unity Diabetes Management System
FDA 510(k), K202145, Bigfoot Unity Diabetes Management System
Device Name: Bigfoot Unity Diabetes Management System
Manufacturer: Kate Lee
Device Classification Name: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Regulation Number: QLG
Classification Product Code: KXA
Date Received: 07/31/2020
Decision Date: 05/07/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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