Data / Medical devices / United States / Icentia LLC
Icentia LLC: FDA-registered device maker in Burlington, VT, United States, 1 510(k) clearance
Icentia LLC is registered with the FDA (registration 3030721635) in Burlington, VT, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030721635
- Address
- 106 Main Street, Burlington, VT, United States, 05401
- Owner or operator
- Icentia LLC (10090390)
- Roles
- Repackager or relabeler
- First device listed
- December 16, 2025
- Registered through
- 2026
- Brand names listed
- CardioSTAT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 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 |
|---|---|---|---|---|---|---|
| March 22, 2023 | K223049 | CardioSTAT® ECG Test Solution | DSH | Substantially Equivalent | Icentia, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 22, 2023. 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.