Neuronaute Plus— 510(k) K231366

Substantially Equivalent

Bioserenity Sas

FDA 510(k) clearance K231366 for Neuronaute Plus, Substantially Equivalent on 2023-11-09. Applicant: Bioserenity Sas. Device class: 2.

Clearance details

Applicant: Bioserenity Sas
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2023-05-11
Decision date: 2023-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWQ

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K260455 — New Wave System2026-03-13
K233403 — Flexset System2024-04-30
K221959 — Q212023-08-31
K231457 — SPARK Scan2023-08-18

More clearances from Bioserenity Sas

K202334 — Neuronaute2020-12-10
K173248 — CARDIOSKIN2018-08-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.