510(k) K191450
K191450 is an FDA 510(k) premarket notification submitted by Dexcom, Inc. for the device "Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on June 28, 2019. The device falls under product code QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated), a Class II device regulated under 21 CFR 862.1355. Dexcom, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2019
- Date Received
- May 31, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Device Class
- Class II
- Regulation Number
- 862.1355
- Review Panel
- CH
- Submission Type
An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.