Cleared Traditional

Neuronaute Plus

K231366 · Bioserenity Sas · Neurology

Nov 2023

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K231366 is an FDA 510(k) clearance for the Neuronaute Plus, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Bioserenity Sas (Paris, FR). The FDA issued a Cleared decision on November 9, 2023, 182 days after receiving the submission on May 11, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K231366 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2023
Decision Date	November 09, 2023
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWQ — Full-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 Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations