Cleared Special

K040113 - SANDMAN SD20 AMPLIFIER

K040113 is an FDA 510(k) clearance for SANDMAN SD20 AMPLIFIER, manufactured by Eb Neuro S.P.A.. The device is a Class 2 Neurology device with product code GWL cleared through the Special 510(k) pathway after a 29-day FDA review.

K040113 · Eb Neuro S.P.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
29d
Days
Class 2
Risk

K040113 is an FDA 510(k) clearance for the SANDMAN SD20 AMPLIFIER. 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 18, 2004 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eb Neuro S.P.A. devices

FDA 510(k) Submission Details - K040113

510(k) Number K040113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date February 18, 2004
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 19
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K040113.
8-CH Electroencephalography Amplifier
K201747 · Hipposcreen Neurotech Corp. · Dec 2020
eego amplifiers
K172312 · Eemagine Medical Imaging Solutions GmbH · Mar 2018
SINGLE AMPLIFIER FOR BOTOX
K051852 · Allergan, Inc. · Sep 2005
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · Nihon Kohden America, Inc. · Sep 1988
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794 · Nihon Kohden America, Inc. · Sep 1987
NICOLET AMP 6R11 SYSTEM
K871678 · Nicolet Biomedical Instruments · Jul 1987