Product code PJT

Device name
Continuous Glucose Monitor Secondary Display
Medical specialty
Clinical Chemistry
Device class
2
Regulation number
862.1350
Review panel
CH
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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
Source
FDA openFDA device classification dataset