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510(k) K251550

NX01 (NX01) by Naox Technologies Sas — Product Code OMC

K251550 is an FDA 510(k) premarket notification submitted by Naox Technologies Sas for the device "NX01 (NX01)". The FDA issued a decision of Substantially Equivalent on November 25, 2025. The device falls under product code OMC (Reduced- Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2025
Date Received
May 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reduced- Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

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 clearances for product code OMC

  • K261101 — Ceribell Monitor (June 30, 2026)
  • K251726 — SignalNED System (Model RE) (September 3, 2025)
  • K243185 — REMI Remote EEG Monitoring System (March 21, 2025)
  • K242930 — Natus BrainWatch System (November 19, 2024)
  • K232779 — QUEX ED; QUEX S (October 11, 2024)
  • K242306 — SignalNED System (Model RE) (September 4, 2024)
  • K230933 — REMI Remote EEG Monitoring System (June 30, 2023)
  • K223628 — NEBA® Compact EEG2R Mobile Headset (March 2, 2023)
  • K221563 — Neurosteer EEG Recorder (October 24, 2022)
  • K203827 — REMI (March 29, 2021)

FDA data resources