510(k) DEN140038
DEN140038 is an FDA 510(k) premarket notification submitted by Dexcom, Inc. for the device "Dexcom Share Direct Secondary Displays". The FDA issued a decision of De Novo Granted on January 23, 2015. The device falls under product code PJT (Continuous Glucose Monitor Secondary Display), a Class II device regulated under 21 CFR 862.1350. Dexcom, Inc. has at least 10 other 510(k) clearances on record.
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