NX01 (NX01)
FDA 510(k) K251550 · Naox Technologies Sas
510(k) numberK251550
Submission
- Device name
- NX01 (NX01)
- Applicant
- Naox Technologies Sas
Paris, FR - Received
- May 21, 2025
- Decision date
- November 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMC – Reduced- Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
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
Other 510(k)s with product code OMC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261101 | Ceribell MonitorOMC · Traditional | Ceribell, Inc. | 06/30/2026SE |
| K251726 | SignalNED System (Model RE)OMC · Traditional | Forest Devices, Inc. | 09/03/2025SE |
| K243185 | REMI Remote EEG Monitoring SystemOMC · Traditional | Epitel | 03/21/2025SE |
| K242930 | Natus BrainWatch SystemOMC · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 11/19/2024SE |
| K232779 | Quex Ed; Quex SOMC · Traditional | Qx World, Ltd. | 10/11/2024SE |
| K242306 | SignalNED System (Model RE)OMC · Traditional | Forest Devices, Inc. | 09/04/2024SE |
| K230933 | REMI Remote EEG Monitoring SystemOMC · Traditional | Epitel, Inc. | 06/30/2023SE |
| K223628 | NEBA® Compact EEG2R Mobile HeadsetOMC · Traditional | Neba Health, LLC | 03/02/2023SE |
| K221563 | Neurosteer EEG RecorderOMC · Traditional | Neurosteer, Inc. | 10/24/2022SE |
| K203827 | RemiOMC · Traditional | Epitel, Inc. | 03/29/2021SE |
Questions and answers
When was NX01 (NX01) cleared by the FDA?
NX01 (NX01) (K251550) received a 510(k) decision of Substantially Equivalent on November 25, 2025, 188 days after the submission was received.
What is the product code of K251550?
The FDA product code is OMC – Reduced- Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.