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FDA 510(k)

Dexcom G6 Pro Continuous Glucose Monitoring System

K-Number: K191833 · 2019-10-07

ApplicantDexcom, Inc.
Decision Date2019-10-07
Product CodeQII
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Dexcom G6 Pro Continuous Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcom, Inc.. It received FDA 510(k) clearance on 2019-10-07 under 510(k) number K191833. The device is classified under product code QII. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dexcom G6 Pro Continuous Glucose Monitoring System?

Dexcom G6 Pro Continuous Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-10-07. The listed applicant is Dexcom, Inc.. The 510(k) number is K191833.

When did Dexcom G6 Pro Continuous Glucose Monitoring System receive FDA 510(k) clearance?

Dexcom G6 Pro Continuous Glucose Monitoring System received FDA 510(k) clearance on 2019-10-07, under 510(k) number K191833.

Who is the listed applicant for Dexcom G6 Pro Continuous Glucose Monitoring System?

The FDA 510(k) record lists Dexcom, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dexcom G6 Pro Continuous Glucose Monitoring System?

The FDA product code for Dexcom G6 Pro Continuous Glucose Monitoring System is QII.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07603284Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi ArabiaACTIVE_NOT_RECRUITINGNCT07681024Global Long-term Outcomes and Real-World Evaluation of Dexcom Continuous Glucose Monitoring System (Dexcom GLOW)NOT_YET_RECRUITINGNCT06601166CONtiNuous glucosE Monitoring (CGM) in People wiTh Type 2 Diabetes Not on InsulinACTIVE_NOT_RECRUITINGNCT04261738Effects of HBO on Glucose in Patients With DMTERMINATEDNCT04386005Continuous Glucose Monitoring in At-Risk NewbornsCOMPLETEDNCT05360056Continuous Glucose Monitoring Following Hospital DischargeACTIVE_NOT_RECRUITING

Other records listing Dexcom, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262472Stelo Glucose Biosensor SystemK260935Stelo Glucose Biosensor SystemK261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring SystemK261359Stelo Glucose Biosensor SystemK253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemK253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System

View all 26 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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