Data / Medical devices / United States / Truepill Ny LLC
Truepill Ny LLC: FDA-registered device maker in Brooklyn, NY, United States, 1 510(k) clearance
Truepill Ny LLC is registered with the FDA (registration 3026572570) in Brooklyn, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 7, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026572570
- Address
- 850 3rd Ave Suite 404, Brooklyn, NY, United States, 11232
- Owner or operator
- Truepill NY LLC (10087232)
- Roles
- Repackager or relabeler
- First device listed
- January 31, 2023
- Registered through
- 2026
- Brand names listed
- Truepill NY
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use | QII | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 7, 2019 | K191833 | Dexcom G6 Pro Continuous Glucose Monitoring System | QII | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
Updated October 7, 2019. 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.