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U.S. Department of Health and Human Services

Devices@FDA
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Help | Download Files | More about CDRH 510(K)

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Device Classification Name Integrated Continuous Glucose Monitoring System, Factory Calibrated
510(k) Number K243214
Device Name Dexcom G7 15 Day Continuous Glucose Monitoring 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 Zachary Nelson
Regulation Number862.1355
Classification Product Code
QBJ  
Subsequent Product Code
KGX  
Date Received10/03/2024
Decision Date 04/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT05263258
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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