Cleared Traditional

Dexcom G6 Pro Continuous Glucose Monitoring System

K191833 · Dexcom, Inc. · Chemistry

Oct 2019

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K191833 is an FDA 510(k) clearance for the Dexcom G6 Pro Continuous Glucose Monitoring System, a Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use (Class II — Special Controls, product code QII), submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on October 7, 2019, 90 days after receiving the submission on July 9, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K191833 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2019
Decision Date	October 07, 2019
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QII — Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1355
Definition	An Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use Is A Continuous Glucose Recording Device Indicated For Use As Directed By A Physician Either For The Real-time Management Of Diabetes At Home Or For The Retrospective Discovery, Analysis, And Interpretation Of Glycemic Variability In Persons Age 2 And Older By Healthcare Professionals To Guide Appropriate Patient Management. The System Is Also Intended To Interface With Digitally Connected Devices.