Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional 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, Dexcom G6 Glucose Program Continuous Glucose Monitoring (cgm) System, Dexcom G6 Professional Continuous Glucose Monitoring (cgm) System.

Pre-market Notification Details

Device IDK221259
510k NumberK221259
Device Name:Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
ClassificationIntegrated Continuous Glucose Monitoring System, Factory Calibrated
Applicant Dexcom, Inc. 6340 Sequence Dr. San Diego,  CA  92121
ContactRachel Ellena
CorrespondentRachel Ellena
Dexcom, Inc. 6340 Sequence Dr. San Diego,  CA  92121
Product CodeQBJ  
Subsequent Product CodeQDK
Subsequent Product CodeQII
CFR Regulation Number862.1355 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-07-29

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.