Cleared Traditional

Dexcom G6 Continuous Glucose Monitoring System

K183206 · Dexcom, Inc. · Chemistry

Feb 2019

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K183206 is an FDA 510(k) clearance for the Dexcom G6 Continuous Glucose Monitoring System, a Integrated Continuous Glucose Monitoring System, Factory Calibrated (Class II — Special Controls, product code QBJ), submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on February 14, 2019, 87 days after receiving the submission on November 19, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K183206 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2018
Decision Date	February 14, 2019
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QBJ — Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1355
Definition	An Integrated Continuous Glucose Monitoring System (icgm) Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control.