510(k) DEN140038
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 23, 2015
- Date Received
- December 15, 2014
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Continuous Glucose Monitor Secondary Display
- Device Class
- Class II
- Regulation Number
- 862.1350
- Review Panel
- CH
- Submission Type
The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring