Cleared Traditional

Neuronaute

K202334 · Bioserenity Sas · Neurology

Dec 2020

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K202334 is an FDA 510(k) clearance for the Neuronaute, 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 December 10, 2020, 115 days after receiving the submission on August 17, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K202334 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2020
Decision Date	December 10, 2020
Days to Decision	115 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