NX01 (NX01)
FDA 510(k) clearance K251550 · decided 2025-11-25
Clearance details
- K-number
- K251550
- Device name
- NX01 (NX01)
- Applicant
- Naox Technologies Sas
- Decision
- Substantially Equivalent
- Date received
- 2025-05-21
- Decision date
- 2025-11-25
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- OMC
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Paris, FR
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Ceribell Monitor (K261101) | Ceribell, Inc. | 2026-06-30 |
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| Natus BrainWatch System (K242930) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-11-19 |
| QUEX ED; QUEX S (K232779) | Qx World, Ltd. | 2024-10-11 |
| SignalNED System (Model RE) (K242306) | Forest Devices, Inc. | 2024-09-04 |
| REMI Remote EEG Monitoring System (K230933) | Epitel, Inc. | 2023-06-30 |
| NEBA® Compact EEG2R Mobile Headset (K223628) | Neba Health, LLC | 2023-03-02 |
| Neurosteer EEG Recorder (K221563) | Neurosteer, Inc. | 2022-10-24 |
| REMI (K203827) | Epitel, Inc. | 2021-03-29 |
| Byteflies Kit (K192549) | Byteflies NV | 2020-06-22 |
| AE-120A EEG Head Set (K183529) | Nihon Kohden Corporation | 2019-03-19 |
Recalls involving this device
No recalls on record reference this clearance.