Product code PJT— Clinical Chemistry
Dexcom Share Direct Secondary Displays
- Classification name
- Continuous Glucose Monitor Secondary Display
- Device class
- Class 2
- Regulation
- 21 CFR 862.1350
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
FDA classification definition
“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”
Market context for product code PJT
FDA has cleared devices under product code PJT, all in 2015, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PJT
Recent clearances under product code PJT
Data sourced from openFDA. This site is unofficial and independent of the FDA.