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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 K253737
Device Name Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
Applicant
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Holly Drake
Correspondent
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Rachel Ellena
Regulation Number862.1355
Classification Product Code
QBJ  
Subsequent Product Code
KGX  
Date Received11/24/2025
Decision Date 02/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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