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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
510(k) Number K200876
Device Name Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
6310 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Maryam Amini
Correspondent
Dexcom, Inc.
6310 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Maryam Amini
Regulation Number862.1355
Classification Product Code
QBJ  
Subsequent Product Code
QDK  
Date Received04/01/2020
Decision Date 12/04/2020
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
Recalls CDRH Recalls
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