Product Code: GWL FDA class 2 21 CFR 882.1835

Amplifier, Physiological Signal

Neurology

The Amplifier, Physiological Signal is a neurological device that amplifies weak bioelectrical signals from the body, such as electroencephalographic (EEG) or electromyographic (EMG) signals, to enable their recording and interpretation during neurological testing. It is an FDA Class 2 device, reflecting moderate risk and requiring 510(k) premarket clearance. The product code is GWL, regulated under 21 CFR 882.1835 in the Neurology specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: GWL
Device Class: FDA class 2
Regulation Number: 882.1835
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243746	Delphi Amplifier	Mar 12, 2025	Substantially Equivalent	Quantalx Neroscience
K242832	NExT Station; NExT Station Advanced	Dec 12, 2024	Substantially Equivalent	Eb Neuro S.P.A.
K242305	BE Plus PRO, Neurotravel LIGHT	Sep 04, 2024	Substantially Equivalent	Eb Neuro S.P.A.
K240646	DreamClear	Sep 04, 2024	Substantially Equivalent	Somnomed Technologies Inc., Doing Business AS Remware
K232210	X-trodes System M	Feb 04, 2024	Substantially Equivalent	X-Trodes
K230148	Vlab	Oct 11, 2023	Substantially Equivalent	Dormotech Medical, Ltd.
K223676	SomniCheck	Jun 01, 2023	Substantially Equivalent	Brainmatterz, LLC
K220631	NomadAir PMU810	Jul 15, 2022	Substantially Equivalent	Neurotronics, Inc.
K203331	Quick-20m	May 20, 2021	Substantially Equivalent	Cgx, LLC
K202174	Digital NeuroPort Biopotential Signal Processing System	Feb 10, 2021	Substantially Equivalent	Blackrock Microsystems
K201747	8-CH Electroencephalography Amplifier	Dec 27, 2020	Substantially Equivalent	Hipposcreen Neurotech Corp.
K172312	eego amplifiers	Mar 30, 2018	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH
K171397	Sienna Ultimate Wireless Amplifier	Oct 06, 2017	Substantially Equivalent	Ems Handels Gesellschaft M.B.H.
K171669	g.Nautilus PRO	Jul 05, 2017	Substantially Equivalent	G.Tec Medical Engineering GmbH
K151600	R-40 EEG Amplifier	Oct 23, 2015	Substantially Equivalent	Lifelines , Ltd.
K133517	NEMUS 2 SYSTEM	Feb 26, 2014	Substantially Equivalent	Eb Neuro S.P.A.
K123255	g.HIamp	Dec 20, 2012	Substantially Equivalent	G.Tec Medical Engineering GmbH
K121996	BE PLUS LTM AMPLIFIER GWI AMPLIFIER	Aug 03, 2012	Substantially Equivalent	Eb Neuro S.P.A.
K103140	NICOLET WIRELESS EEG	Apr 08, 2011	Substantially Equivalent	Carefusion 209, Inc.
K092699	NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800	Mar 18, 2010	Substantially Equivalent	Neurotronics, Inc.
K090957	BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM	May 28, 2009	Substantially Equivalent	I2s Micro Implantable Systems, LLC
K083322	NEUROMETRIX BIOAMPLIFIER	May 27, 2009	Substantially Equivalent	Neurometrix, Inc.
K063599	PORTI 7 PHYSIOLOGICAL AMPLIFIER	Mar 22, 2007	Substantially Equivalent	Tms International BV
K060374	REFA, PHYSIOLOGICAL AMPLIFIER	May 30, 2006	Substantially Equivalent	Tms International BV
K060803	G.USBAMP	May 02, 2006	Substantially Equivalent	G.Tec Medical Engineering GmbH
K053606	BE PLUS / AURA-LTM64 AMPLIFIER	Jan 24, 2006	Substantially Equivalent	Eb Neuro S.P.A.
K051852	SINGLE AMPLIFIER FOR BOTOX	Sep 14, 2005	Substantially Equivalent	Allergan, Inc.
K052060	OPTI-AMP DC-POWERED	Aug 31, 2005	Substantially Equivalent	Intelligent Hearing Systems
K041198	NIC36 AMPLIFIER	Jun 01, 2004	Substantially Equivalent	Eb Neuro S.P.A.
K040113	SANDMAN SD20 AMPLIFIER	Feb 18, 2004	Substantially Equivalent	Eb Neuro S.P.A.
K003154	MIZAR, BASIS BE, SANDMAN DIGITAL	Jan 05, 2001	Substantially Equivalent	Eb Neuro S.P.A.
K972515	SENSOR AMPLIFIER	Oct 02, 1997	Substantially Equivalent	Pro-Tech Services, Inc.
K963669	GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM	Dec 12, 1996	Substantially Equivalent	Astro-Med, Inc.
K943673	MMC AMPLIFIER	Oct 26, 1994	Substantially Equivalent	Melville Software , Ltd.
K914876	OPTI-AMP	Jan 10, 1992	Substantially Equivalent	Intelligent Hearing Systems
K912436	AM-PAK	Oct 18, 1991	Substantially Equivalent	Cns, Inc.
K901797	THE WONDER BOX	Feb 07, 1991	Substantially Equivalent	Micro Tronics Corp.
K904222	VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER	Jan 18, 1991	Substantially Equivalent	Telediagnostic Systems, Inc.
K900063	MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)	Feb 16, 1990	Substantially Equivalent	Bio-Feedback Systems, Inc.
K884071	AMPLAID EMG15	Feb 27, 1989	Substantially Equivalent	Amplus Corp.
K881177	MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD	Sep 30, 1988	Substantially Equivalent	Nihon Kohden America, Inc.
K880773	THE VENUS SYSTEM	Aug 18, 1988	Substantially Equivalent	Neuroscientific Corp.
K870794	MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER	Sep 30, 1987	Substantially Equivalent	Nihon Kohden America, Inc.
K871678	NICOLET AMP 6R11 SYSTEM	Jul 16, 1987	Substantially Equivalent	Nicolet Biomedical Instruments
K860289	PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER	Aug 25, 1986	Substantially Equivalent	Professional Health Technologies, Inc.
K861014	AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)	Aug 20, 1986	Substantially Equivalent	Amplaid USA, Inc.
K841612	NEUROPACK II 5100	Jun 07, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K833413	COMPUTERSCOPE CPS-ABR	Nov 28, 1983	Substantially Equivalent	Rc Electronics, Inc.
K821250	METRACO EVOKED POTENTIAL SYSTEM	Jul 02, 1982	Substantially Equivalent	Metraco, Inc.
K781743	RESPONSE SYSTEM, TN-3000	Dec 01, 1978	Substantially Equivalent	Tracor Instruments, Inc.
K781289	PREAMPLIFIER MODEL 113	Sep 14, 1978	Substantially Equivalent	Princeton Applied Research Corp.
K772102	AMPLIFIER OTRONA, MODEL N3A-EMG	Nov 21, 1977	Substantially Equivalent	Honeywell, Inc.
K771683	AMPLIFIER MODEL N3B-EEG	Sep 20, 1977	Substantially Equivalent	Honeywell, Inc.