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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 K191450
Device Name Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
6310 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Emily Chung
Correspondent
Dexcom, Inc.
6310 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Emily Chung
Regulation Number862.1355
Classification Product Code
QBJ  
Subsequent Product Codes
QDK   QDL  
Date Received05/31/2019
Decision Date 06/28/2019
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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