PJT — Continuous Glucose Monitor Secondary Display Class II
FDA product code PJT covers "Continuous Glucose Monitor Secondary Display", a Class II medical device regulated under 21 CFR 862.1350. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.
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