Data / Medical devices / United States / Epitel
Epitel: FDA-registered device maker in Salt Lake City, UT, United States, 2 510(k) clearances
Epitel is registered with the FDA (registration 3014692331) in Salt Lake City, UT, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014692331
- Address
- 465 South 400 East Suite 250, Salt Lake City, UT, United States, 84111
- Owner or operator
- Epitel (10082545)
- Roles
- Manufacturer
- First device listed
- January 11, 2024
- Registered through
- 2026
- Brand names listed
- REMI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automatic Event Detection Software For Full-Montage Electroencephalograph | OMB | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 2 | 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 21, 2025 | K243185 | REMI Remote EEG Monitoring System | OMC | Substantially Equivalent | Epitel | accessdata.fda.gov |
| January 3, 2024 | K231779 | REMI AI Discrete Detection Module | OMB | Substantially Equivalent | Epitel, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Reduced- Montage Standard Electroencephalograph
- All makers of Automatic Event Detection Software For Full-Montage Electroencephalograph
Updated March 21, 2025. 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.