Cleared Traditional

NEMUS 2 SYSTEM

K133517 · Eb Neuro S.P.A. · Neurology
Feb 2014
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K133517 is an FDA 510(k) clearance for the NEMUS 2 SYSTEM, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Eb Neuro S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on February 26, 2014, 103 days after receiving the submission on November 15, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K133517 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2013
Decision Date February 26, 2014
Days to Decision 103 days
Submission Type Traditional
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