Cleared Traditional

K202334 - Neuronaute

K202334 is an FDA 510(k) clearance for Neuronaute, manufactured by Bioserenity Sas. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K202334 · Bioserenity Sas · Neurology device
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Dec 2020
Decision
115d
Days
Class 2
Risk

K202334 is an FDA 510(k) clearance for the Neuronaute. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Bioserenity Sas (Paris, FR). The FDA issued a Cleared decision on December 10, 2020 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioserenity Sas devices

FDA 510(k) Submission Details - K202334

510(k) Number K202334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 148d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWQ Full-montage Standard Electroencephalograph

All 96
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