510(k) K191833
K191833 is an FDA 510(k) premarket notification submitted by Dexcom, Inc. for the device "Dexcom G6 Pro Continuous Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on Oct 7, 2019. The device falls under product code QII (Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use), a Class II device regulated under 21 CFR 862.1355. Dexcom, Inc. has 27 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 7, 2019
- Date Received
- Jul 9, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
- Device Class
- Class II
- Regulation Number
- 862.1355
- Review Panel
- CH
- Submission Type
- 510(k)
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.