Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System

Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management

Dexcom, Inc.

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

Pre-market Notification Details

Device IDK192787
510k NumberK192787
Device Name:Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
ClassificationIntegrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management
Applicant Dexcom, Inc. 6310 Sequence Dr. San Diego,  CA  92121
ContactBryan Osborne
CorrespondentBryan Osborne
Dexcom, Inc. 6340 Sequence Dr. San Diego,  CA  92121
Product CodeQDK  
CFR Regulation Number862.1355 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2019-10-25
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.