510(k) K251550

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

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

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