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U.S. Department of Health and Human Services

Devices@FDA
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Device Classification Name Integrated Continuous Glucose Monitoring System, Factory Calibrated
510(k) Number K183206
Device Name Dexcom G6 Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
6310 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Bryan Osborne
Correspondent
Dexcom, Inc.
6310 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Bryan Osborne
Regulation Number862.1355
Classification Product Code
QBJ  
Date Received11/19/2018
Decision Date 02/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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