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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 retrospective use
510(k) Number K182405
Device Name Dexcom Pro Q Continuous Glucose Monitoring System
Dexcom, Inc
6310 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Luke Olson
Dexcom, Inc
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Luke Olson
Regulation Number862.1355
Classification Product Code
Date Received09/04/2018
Decision Date 11/02/2018
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