PJT — Continuous Glucose Monitor Secondary Display Class II

FDA Device Classification

Classification Details

Product Code
PJT
Device Class
Class II
Regulation Number
862.1350
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K151236medtronic minimedMiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink ConMay 19, 2015
DEN140038dexcomDexcom Share Direct Secondary DisplaysJanuary 23, 2015