PJT · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1350
Classification
FDA Product Code
PJT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1350
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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