Dexcom G6 Continuous Glucose Monitoring (CGM) 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 (cgm) System.

Pre-market Notification Details

Device IDK201328
510k NumberK201328
Device Name:Dexcom G6 Continuous Glucose Monitoring (CGM) System
ClassificationIntegrated Continuous Glucose Monitoring System, Factory Calibrated
Applicant Dexcom, Inc. 6310 Sequence Dr. San Diego,  CA  92121
ContactMaryam Amini
CorrespondentMaryam Amini
Dexcom, Inc. 6310 Sequence Dr. San Diego,  CA  92121
Product CodeQBJ  
CFR Regulation Number862.1355 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-19
Decision Date2021-07-15

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