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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 for professional directed retrospective or real-time use
510(k) Number K191833
Device Name Dexcom G6 Pro Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
6310 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Jacob Nardone
Correspondent
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Jacob Nardone
Regulation Number862.1355
Classification Product Code
QII  
Date Received07/09/2019
Decision Date 10/07/2019
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
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