Cleared Special

BE Plus PRO, Neurotravel LIGHT

K242305 · Eb Neuro S.P.A. · Neurology
Sep 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K242305 is an FDA 510(k) clearance for the BE Plus PRO, Neurotravel LIGHT, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Eb Neuro S.P.A. (Firenze, IT). The FDA issued a Cleared decision on September 4, 2024, 30 days after receiving the submission on August 5, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K242305 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2024
Decision Date September 04, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835