Cleared Special

BE PLUS LTM AMPLIFIER GWI AMPLIFIER

K121996 · Eb Neuro S.P.A. · Neurology
Aug 2012
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K121996 is an FDA 510(k) clearance for the BE PLUS LTM AMPLIFIER GWI AMPLIFIER, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Eb Neuro S.P.A. (Indianapolis, US). The FDA issued a Cleared decision on August 3, 2012, 25 days after receiving the submission on July 9, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K121996 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2012
Decision Date August 03, 2012
Days to Decision 25 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