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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 K240902
Device Name Dexcom G7 Continuous Glucose Monitoring System
Applicant
Dexcom Inc.
6340 Sequence Dr
San Diego,  CA  92121
Applicant Contact Neeta Sharma
Correspondent
Dexcom Inc.
6340 Sequence Dr
San Diego,  CA  92121
Correspondent Contact Bob Shen
Regulation Number862.1355
Classification Product Code
QBJ  
Subsequent Product Code
KGX  
Date Received04/02/2024
Decision Date 04/23/2024
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
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