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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
510(k) Number K222280
Device Name Bigfoot Unity® Diabetes Management System
Applicant
Bigfoot Biomedical, Inc.
1820 Mccarthy Blvd.
Milpitas,  CA  95035
Applicant Contact Kate Lee
Correspondent
Bigfoot Biomedical, Inc.
1820 Mccarthy Blvd.
Milpitas,  CA  95035
Correspondent Contact Kate Lee
Regulation Number862.1355
Classification Product Code
QLG  
Subsequent Product Code
QOG  
Date Received07/29/2022
Decision Date 03/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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