510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170138Substantially Equivalent

Neuronaute

Bioserenity, Paris, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170138 is the FDA 510(k) clearance record for NEURONAUTE, a class II device, cleared for Bioserenity on under FDA product code GWQ (Full-Montage Standard Electroencephalograph). FDA's definition for product code GWQ reads: "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". FDA records list 2 510(k) clearances for Bioserenity, from to . As of , FDA records show no recalls naming K170138.

Clearance record

Decision date
Received
(343 days to decision)
Product code
GWQ Full-Montage Standard Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Bioserenity 47 Blvd. De L'Hopital, Paris, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWQ

Trailing 12 months
2 clearances under product code GWQ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260