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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 K202145
Device Name Bigfoot Unity Diabetes Management System
Bigfoot Biomedical, Inc.
1820 McCarthy Blvd
Milpitas,  CA  95035
Applicant Contact Kate Lee
Bigfoot Biomedical, Inc.
1820 McCarthy Blvd
Milpitas,  CA  95035
Correspondent Contact Kate Lee
Regulation Number862.1355
Classification Product Code
Subsequent Product Code
Date Received07/31/2020
Decision Date 05/07/2021
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