Data / Medical devices / Continuous Glucose Monitor Secondary Display
Continuous Glucose Monitor Secondary Display (PJT): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Continuous Glucose Monitor Secondary Display (product code PJT, Class 2, 21 CFR 862.1350). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on May 19, 2015, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PJT
- Device class
- 2
- Regulation
- 862.1350
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Finland | 1 |
| India | 1 |
| China | 1 |
Makers of Continuous Glucose Monitor Secondary Display
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Dexcom, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | January 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Intricon Corporation | Arden Hills, MN, United States | Manufacturer | 1 | May 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer | 1 | May 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diabetes Care Inc. | Alameda, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atulo Products | Newton, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harald Ai OY | Espoo Etela-Karjala, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Senseonics, Inc. | Germantown, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skytech Electronics (HK) Limited | Tsim Sha Tsui Hong Kong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welldoc | Columbia, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 19, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.