Dexcom G6 Pro Continuous Glucose Monitoring System
FDA 510(k) K191833 · Dexcom, Inc.
Submission
- Device name
- Dexcom G6 Pro Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
San Diego, CA, US - Received
- July 9, 2019
- Decision date
- October 7, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QII – Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1355
- Specialty
- Clinical Chemistry
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…
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Questions and answers
When was Dexcom G6 Pro Continuous Glucose Monitoring System cleared by the FDA?
Dexcom G6 Pro Continuous Glucose Monitoring System (K191833) received a 510(k) decision of Substantially Equivalent on October 7, 2019, 90 days after the submission was received.
What is the product code of K191833?
The FDA product code is QII – Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use, a Class II (moderate risk) device regulated under 21 CFR 862.1355.