Cleared Special

NExT Station; NExT Station Advanced

K242832 · Eb Neuro S.P.A. · Neurology
Dec 2024
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K242832 is an FDA 510(k) clearance for the NExT Station; NExT Station Advanced, 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 December 12, 2024, 84 days after receiving the submission on September 19, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K242832 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2024
Decision Date December 12, 2024
Days to Decision 84 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