PJT

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Continuous Glucose Monitor Secondary Display

Device class

Class II (moderate risk)

Regulation

21 CFR 862.1350

Medical specialty

Clinical Chemistry

FDA 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

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