OMC
- Product code
- OMC
- Device name
- Reduced- Montage Standard Electroencephalograph
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1400
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 29
FDA classification definition
Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261101 | 2026-06-30 | Ceribell, Inc. | Ceribell Monitor | |
| K251550 | 2025-11-25 | Naox Technologies Sas | NX01 (NX01) | |
| K251726 | 2025-09-03 | Forest Devices, Inc. | SignalNED System (Model RE) | |
| K243185 | 2025-03-21 | Epitel | REMI Remote EEG Monitoring System | |
| K242930 | 2024-11-19 | Natus Medical Incorporated Dba Excel-T | Natus BrainWatch System | |
| K232779 | 2024-10-11 | Qx World, Ltd. | QUEX ED; QUEX S | |
| K242306 | 2024-09-04 | Forest Devices, Inc. | SignalNED System (Model RE) |
Official FDA classification page: OMC
Classification and pathway per current FDA publications. Data from openFDA (CC0).