Total clearances
5
2021-03-29 → 2025-03-21
Name variants in FDA filings: Epitel, Inc. / Epitel
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| OMC |
Reduced- Montage Standard Electroencephalograph |
Class II |
Neurology |
3 |
2025-03-21 |
| OMB |
Automatic Event Detection Software For Full-Montage Electroencephalograph |
Class II |
Neurology |
2 |
2024-10-17 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-03-21 |
K243185 |
REMI Remote EEG Monitoring System |
OMC |
Class II |
Neurology |
| 2024-10-17 |
K240408 |
REMI-AI Rapid Detection Module (REMI-AI RDM) |
OMB |
Class II |
Neurology |
| 2024-01-03 |
K231779 |
REMI AI Discrete Detection Module |
OMB |
Class II |
Neurology |
| 2023-06-30 |
K230933 |
REMI Remote EEG Monitoring System |
OMC |
Class II |
Neurology |
| 2021-03-29 |
K203827 |
REMI |
OMC |
Class II |
Neurology |