510(k) K191833

Device

Dexcom G6 Pro Continuous Glucose Monitoring System

Applicant

Dexcom, Inc.

510(k) number

K191833

Product code

QII  

Decision

Substantially Equivalent (SESE)

Decision date

2019-10-07

Date received

2019-07-09

Regulation

862.1355

Classification name

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-time Use

Medical specialty

Clinical Chemistry

Review panel

Clinical Chemistry

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No