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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 K231081
Device Name Dexcom G7 Continuous Glucose Monitoring (CGM) System
Applicant
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Bob Shen
Correspondent
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Bob Shen
Regulation Number862.1355
Classification Product Code
QBJ  
Date Received04/17/2023
Decision Date 05/15/2023
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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