Data / Medical devices / Canada / ICENTIA Inc
ICENTIA Inc: FDA-registered device maker in Quebec, Canada, 1 510(k) clearance
ICENTIA Inc is registered with the FDA (registration 3014271754) in Quebec, Canada. It lists 5 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
- 3014271754
- Address
- 2750 rue Einstein, Quebec, Canada, G1P 4R1
- Owner or operator
- Icentia.com (10082168)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 22, 2021
- Registered through
- 2026
- Brand names listed
- 3M Red Dot, CardioSTAT ECG Test Solution, OFIX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Razor, Surgical | LWK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | 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
- All makers of Electrode, Electrocardiograph
- All makers of Razor, Surgical
- All makers of Tape And Bandage, Adhesive
- All makers of Computer, Diagnostic, Programmable
- All makers of Recorder, Magnetic Tape, Medical
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.