Continuous Glucose Monitor Secondary Display
The Continuous Glucose Monitor Secondary Display is a device that provides real-time secondary notification of a patient's continuous glucose monitoring sensor glucose data to a designated follower (such as a caregiver or family member), without replacing the primary CGM system or standard home blood glucose monitoring. It is an FDA Class 2 device regulated under 21 CFR 862.1350, within the Clinical Chemistry (CH) specialty. The product code is PJT. This device is not an implant and is not life-sustaining.
Basic Information
- Product Code
- PJT
- Device Class
- FDA class 2
- Regulation Number
- 862.1350
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) | May 19, 2015 | Substantially Equivalent | MEDTRONIC MINIMED, INC. |
| DEN140038 | Dexcom Share Direct Secondary Displays | Jan 23, 2015 | Unknown | DEXCOM, INC. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.