Cleared Traditional

K133517 - NEMUS 2 SYSTEM

K133517 is an FDA 510(k) clearance for NEMUS 2 SYSTEM, manufactured by Eb Neuro S.P.A.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K133517 · Eb Neuro S.P.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
103d
Days
Class 2
Risk

K133517 is an FDA 510(k) clearance for the NEMUS 2 SYSTEM. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Eb Neuro S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on February 26, 2014 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eb Neuro S.P.A. devices

FDA 510(k) Submission Details - K133517

510(k) Number K133517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 149d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWL Device Classification - Class 2, Special Controls

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWL Amplifier, Physiological Signal

All 37
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K133517.
Sienna Ultimate Wireless Amplifier
K171397 · Ems Handels Gesellschaft M.B.H. · Oct 2017
g.Nautilus PRO
K171669 · G.Tec Medical Engineering GmbH · Jul 2017
R-40 EEG Amplifier
K151600 · Lifelines , Ltd. · Oct 2015
g.HIamp
K123255 · G.Tec Medical Engineering GmbH · Dec 2012
BE PLUS LTM AMPLIFIER GWI AMPLIFIER
K121996 · Eb Neuro S.P.A. · Aug 2012
NICOLET WIRELESS EEG
K103140 · Carefusion 209, Inc. · Apr 2011