Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System And Dexcom Pro Q Continuous Glucose Monitoring System

Integrated Continuous Glucose Monitoring System, Factory Calibrated

Dexcom, Inc.

The following data is part of a premarket notification filed by Dexcom, Inc. with the FDA for Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System And Dexcom Pro Q Continuous Glucose Monitoring System.

Pre-market Notification Details

Device IDK191450
510k NumberK191450
Device Name:Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System And Dexcom Pro Q Continuous Glucose Monitoring System
ClassificationIntegrated Continuous Glucose Monitoring System, Factory Calibrated
Applicant Dexcom, Inc. 6310 Sequence Dr. San Diego,  CA  92121
ContactEmily Chung
CorrespondentEmily Chung
Dexcom, Inc. 6310 Sequence Dr. San Diego,  CA  92121
Product CodeQBJ  
Subsequent Product CodeQDK
Subsequent Product CodeQDL
CFR Regulation Number862.1355 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-31
Decision Date2019-06-28

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