Cleared Traditional

NX01 (NX01)

K251550 · Naox Technologies Sas · Neurology

Nov 2025

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K251550 is an FDA 510(k) clearance for the NX01 (NX01), a Reduced- Montage Standard Electroencephalograph (Class II — Special Controls, product code OMC), submitted by Naox Technologies Sas (Paris, FR). The FDA issued a Cleared decision on November 25, 2025, 188 days after receiving the submission on May 21, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K251550 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2025
Decision Date	November 25, 2025
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMC — Reduced- Montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
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