510(k) K203089
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2021
- Date Received
- October 13, 2020
- Clearance Type
- Traditional
- 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.