510(k) K193642
K193642 is an FDA 510(k) premarket notification submitted by Dexcom, Inc. for the device "Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System". The FDA issued a decision of Substantially Equivalent on January 29, 2020. The device falls under product code QDK (Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management), 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
- January 29, 2020
- Date Received
- December 30, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
- Device Class
- Class II
- Regulation Number
- 862.1355
- Review Panel
- CH
- Submission Type
An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.