PJTClass II
Continuous Glucose Monitor Secondary Display
21 CFR 862.1350 / Clinical Chemistry
PJT is the FDA product code for Continuous Glucose Monitor Secondary Display, a class II device type, regulated under 21 CFR 862.1350. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PJT
- Device name
- Continuous Glucose Monitor Secondary Display
- 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
- Regulation
- 21 CFR 862.1350
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code PJT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2015 | 2 |
Applicants with the most clearances
Product code PJT| Applicant | Clearances |
|---|---|
| Dexcom, Inc. | 1 |
| Medtronic, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.