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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 K223931
Device Name Dexcom G6 Continuous Glucose Monitoring (CGM) System
Applicant
Dexcom, Inc.
6340 Sequence Drive
San Diego,  CA  92121
Applicant Contact Brittney Shaver
Correspondent
Dexcom, Inc.
6340 Sequence Drive
San Diego,  CA  92121
Correspondent Contact Brittney Shaver
Regulation Number862.1355
Classification Product Code
QBJ  
Date Received12/30/2022
Decision Date 01/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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