Product Code: GWQ FDA class 2 21 CFR 882.1400

Full-Montage Standard Electroencephalograph

Neurology

The Full-Montage Standard Electroencephalograph (EEG) is a neurological diagnostic device that acquires, displays, stores, and archives electroencephalographic signals from the brain using a full montage array of 16 or more electrodes at user-specified locations, enabling comprehensive assessment of brain electrical activity for the diagnosis of epilepsy, sleep disorders, and other neurological conditions. It is an FDA Class 2 device, requiring 510(k) premarket clearance. The product code is GWQ, regulated under 21 CFR 882.1400 in the Neurology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

189

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GWQ
Device Class: FDA class 2
Regulation Number: 882.1400
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 189 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261604	Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)	Jun 13, 2026	Substantially Equivalent	Neuroelectrics Barcelona S.L.U.
K260455	New Wave System	Mar 13, 2026	Substantially Equivalent	Zeto, Inc.
K233403	Flexset System	Apr 30, 2024	Substantially Equivalent	Zeto, Inc.
K231366	Neuronaute Plus	Nov 09, 2023	Substantially Equivalent	Bioserenity Sas
K221959	Q21	Aug 31, 2023	Substantially Equivalent	Neurofield, Inc.
K231457	SPARK Scan	Aug 18, 2023	Substantially Equivalent	Spark Neuro, Inc.
K221963	Cumulus Functional Neurophysiology Platform	Apr 27, 2023	Substantially Equivalent	Cumulus Neuroscience Limited
K230073	Okti	Feb 09, 2023	Substantially Equivalent	Compumedics Limited
K223644	Neuronaute with IceCap 2 & IceCap 2 Small	Jan 12, 2023	Substantially Equivalent	Bioserenity
K220056	iSyncWave	Aug 10, 2022	Substantially Equivalent	iMediSync, Inc.
K212788	Seer Home	Jun 16, 2022	Substantially Equivalent	Seer Medical Pty, Ltd.
K213900	WAVi SCAN EEG System and Accessories	May 06, 2022	Substantially Equivalent	Wavi Co.
K193159	NeuroAmp II, NeuroAmp II.5s	Dec 30, 2020	Substantially Equivalent	Corscience GmbH & Co. KG
K202334	Neuronaute	Dec 10, 2020	Substantially Equivalent	Bioserenity Sas
K201819	Cadwell Apollo System	Sep 29, 2020	Substantially Equivalent	Cadwell Industries, Inc.
K191492	Maxxi Position Sensor	Apr 24, 2020	Substantially Equivalent	Neurovirtual USA, Inc.
K191868	iCEWav Neuromonitoring Platform	Mar 31, 2020	Substantially Equivalent	Ice Neurosystems, Inc.
K192753	NeuralScan System	Mar 17, 2020	Substantially Equivalent	Medeia, Inc.
K181466	Cadwell Zenith System	Sep 01, 2018	Substantially Equivalent	Cadwell Industries, Inc.
K180269	Cadwell Apollo System	Jul 17, 2018	Substantially Equivalent	Cadwell Industries, Inc.
K180290	Natus Brain Monitor Amplifier	Jun 14, 2018	Substantially Equivalent	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K172271	Trackit T4 EEG Amplifier	May 04, 2018	Substantially Equivalent	Lifelines , Ltd.
K172735	WR19 System	Apr 17, 2018	Substantially Equivalent	Zeto, Inc.
K180181	Natus Quantum	Feb 22, 2018	Substantially Equivalent	Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)
K173460	NeuroEEG	Feb 16, 2018	Substantially Equivalent	Memory MD, Inc.
K171384	Micromed BRAIN QUICK system	Feb 01, 2018	Substantially Equivalent	Micromed S.P.A.
K170138	NEURONAUTE	Dec 26, 2017	Substantially Equivalent	Bioserenity
K171781	eVox System	Dec 13, 2017	Substantially Equivalent	Evoke Neuroscience, Inc.
K171124	Nihon Kohden Wireless Input Unit WEE-1200	Aug 25, 2017	Substantially Equivalent	Nihon Kohden Corporation
K170441	ElectroTek	Jun 05, 2017	Substantially Equivalent	Mobilemedtek
K162681	Enobio Wireless EEG	Jun 02, 2017	Substantially Equivalent	Neuroelectrics Barcelona S.L.U.
K163163	XLTEK EMU40EX EEG Headbox	Dec 14, 2016	Substantially Equivalent	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K162595	Trex_HD	Nov 04, 2016	Substantially Equivalent	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K150498	Discovery 24	Jan 26, 2016	Substantially Equivalent	Brainmaster Technologies, Inc.
K143233	Mitsar-EEG	Aug 13, 2015	Substantially Equivalent	Mitsar Co., Ltd.
K143440	Natus Quantum	Apr 20, 2015	Substantially Equivalent	Natus Medical Incorporated
K131335	BWMINI EEG, BWMINIHST, BWMINI PSG	Feb 03, 2015	Substantially Equivalent	Neurovirtual USA, Inc.
K131266	TREZ_HD	Feb 14, 2014	Substantially Equivalent	Excel-Tech Ltd. (Xltek)
K133355	CADWELL FLEX EEG/PSG	Jan 29, 2014	Substantially Equivalent	Cadwell Industries, Inc.
K131383	X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE	Nov 27, 2013	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K122196	CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY	May 02, 2013	Substantially Equivalent	Blackrock Neuromed, LLC
K120888	PSG-1100 SLEEP DIAGNOSTIC SYSTEM	Nov 09, 2012	Substantially Equivalent	Nihon Kohden Corp.
K112817	MICROEEG SYSTEM	Jun 19, 2012	Substantially Equivalent	Bio-Signal Group Corporation
K113117	NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX	Mar 22, 2012	Substantially Equivalent	Nihon Kohden America, Inc.
K112353	GEODESIC EEG MOBILE 100 (GEM 100)	Feb 17, 2012	Substantially Equivalent	Electrical Geodesics, Inc.
K112107	BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS	Oct 28, 2011	Substantially Equivalent	Neurovirtual USA, Inc.
K083577	HARMONIE SYSTEM	Aug 29, 2011	Substantially Equivalent	Stellate Systems
K110376	PE-210AK SWITCH BOX	Jul 29, 2011	Substantially Equivalent	Nihon Kohden Corp.
K103129	ENTROPY EASYFIT SENSOR	Jul 19, 2011	Substantially Equivalent	GE Healthcare
K101386	VIGILANT EEG MONITOR MODEL VIGILANT 2.0	Jul 30, 2010	Substantially Equivalent	Infinite Biomedical Technologies, LLC
K100683	NEUROLINK IP MODEL: PK1117	Apr 09, 2010	Substantially Equivalent	Natus Medical Incorporated
K093223	COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG	Jan 15, 2010	Substantially Equivalent	Compumedics Limited
K081741	NEUROLINK IP, MODEL PK1113	Oct 31, 2008	Substantially Equivalent	Excel-Tech Ltd. (Xltek)
K081151	COMPUMEDICS NEUVO	Sep 08, 2008	Substantially Equivalent	Compumedics USA, Ltd.
K071109	SACS EEG WORKSTATION A7	Jun 07, 2007	Substantially Equivalent	Sacs Medical AB
K061908	NICOLETONE SYSTEM V32 AMPLIFIER	Nov 06, 2006	Substantially Equivalent	Viasys Neuro Care
K053386	XLTEK EMU40 EEG HEADBOX, MODEL PK1072	Apr 21, 2006	Substantially Equivalent	Excel Tech. , Ltd.
K051825	COGNITRACE	Sep 12, 2005	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH
K042626	NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM	Mar 28, 2005	Substantially Equivalent	Cyberkinetics, Inc.
K043309	GEODESIC PHOTOGRAMMETRY SYSTEM	Jan 26, 2005	Substantially Equivalent	Electrical Geodesics, Incorporated
K042150	XLTEK TREX MODEL#10309	Aug 27, 2004	Substantially Equivalent	Excel Tech. , Ltd.
K033399	GEODESIC EEG SYSTEM SERIES 100	Aug 04, 2004	Substantially Equivalent	Electrical Geodesics, Incorporated
K040554	ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256	Jul 16, 2004	Substantially Equivalent	Manufacturing Technology, Inc.
K040360	EMU128S, MODEL EX-NW-128S	Mar 12, 2004	Substantially Equivalent	Excel Tech. , Ltd.
K033978	ADAM	Feb 18, 2004	Substantially Equivalent	Astro-Med, Inc.
K023771	SYNAMPS2	Feb 06, 2003	Substantially Equivalent	Neuroscan
K022785	EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION	Oct 09, 2002	Substantially Equivalent	Axon Systems, Inc.
K021599	96 CHANNEL EEG HEADBOX MODEL EMU96	Aug 13, 2002	Substantially Equivalent	Excel Tech. , Ltd.
K014147	80 CHANNEL EEG	Jan 14, 2002	Substantially Equivalent	Xltek
K014146	84 CHANNEL EEG	Jan 14, 2002	Substantially Equivalent	Xltek
K010997	PAM-RL	Oct 15, 2001	Substantially Equivalent	Individual Monitoring Systems, Inc.
K012079	GEODESIC EEG SYSTEM, MODEL 200	Sep 19, 2001	Substantially Equivalent	Electrical Geodesics, Incorporated
K010697	UNIQUE AMBULATORY EEG	Jun 06, 2001	Substantially Equivalent	Axon Systems, Inc.
K010669	NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1	Jun 04, 2001	Substantially Equivalent	Thuris Corp.
K011430	ACTIWARE-PLMS	May 31, 2001	Substantially Equivalent	Mini-Mitter Co., Inc.
K010086	REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)	Apr 09, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K010089	REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)	Mar 26, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K010088	REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)	Mar 26, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K010084	REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP	Mar 16, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K010150	64 CHANNEL EEG / MODEL NUMBER EX-NW-64	Feb 09, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K010091	EEG WITH VIDEO, MODEL EX-NW	Feb 01, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K002316	PHOENIX DIGITAL EEG	Oct 26, 2000	Substantially Equivalent	Axon Systems, Inc.
K002570	BIO-LOGIC CEEGRAPH NETLINK	Sep 14, 2000	Substantially Equivalent	Bio-Logic Systems Corp.
K000919	128 CHANNEL EEG HEADBOX, MODEL EX-NW-128	Aug 31, 2000	Substantially Equivalent	Excel Tech. , Ltd.
K001103	WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)	Jun 30, 2000	Substantially Equivalent	Excel Tech. , Ltd.
K000898	EEG WITH VIDEO, MODEL EX-NW	Apr 14, 2000	Substantially Equivalent	Excel Tech. , Ltd.
K991054	BRAVO MULTI-MODALITY SYSTEM	Nov 03, 1999	Substantially Equivalent	Nicolet Biomedical, Inc.
K992410	ACTITRAC	Oct 15, 1999	Substantially Equivalent	Individual Monitoring Systems, Inc.
K991033	ACTIWATCH-SCORE	Jun 23, 1999	Substantially Equivalent	Mini-Mitter Co., Inc.
K983533	ACTIWATCH	Mar 23, 1999	Substantially Equivalent	Mini-Mitter Co., Inc.
K982479	EXCEL AMBULATORY EEG	Oct 14, 1998	Substantially Equivalent	Excel Tech. , Ltd.
K980214	EXCEL NEURO WORKS	Apr 21, 1998	Substantially Equivalent	Excel Tech. , Ltd.
K973883	BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM	Mar 05, 1998	Substantially Equivalent	Bio-Logic Systems Corp.
K974495	NEUROAMP EEG AMPLIFIER	Feb 26, 1998	Substantially Equivalent	Neurocorp, Ltd.
K971329	CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)	Nov 20, 1997	Substantially Equivalent	Ctf Systems, Inc.
K972202	DEEG-LITE	Jul 23, 1997	Substantially Equivalent	Grass-Telefactor Product Group
K971331	SATELLITE	Jun 25, 1997	Substantially Equivalent	Nicolet Biomedical, Inc.
K970942	MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM	Jun 02, 1997	Substantially Equivalent	Physiometrix, Inc.
K970703	GALILEO HALLEY	May 19, 1997	Substantially Equivalent	Biosound Esaote, Inc.
K964280	DG NERVUS	Jan 27, 1997	Substantially Equivalent	Medelec , Ltd.
K961642	MEDILOG MR95	Jan 17, 1997	Substantially Equivalent	Oxford Instruments, Plc.
K962447	EQUINOX DIGITAL EEG SYSTEM	Dec 12, 1996	Substantially Equivalent	Physiometrix, Inc.
K962157	MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM	Nov 25, 1996	Substantially Equivalent	Physiometrix, Inc.
K954954	CEEGRAPH TRAVELER AMBULATORY EEG RECORDER	Jan 25, 1996	Substantially Equivalent	Bio-Logic Systems Corp.
K953449	MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS	Oct 12, 1995	Substantially Equivalent	Physiometrix, Inc.
K946094	CADWELL EASY AMBULATORY EEG	Sep 12, 1995	Substantially Equivalent	Cadwell Laboratories, Inc.
K951507	PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE	Jul 14, 1995	Substantially Equivalent	Neuroconcepts, Inc.
K944678	NIHON KOHDEN ELECTROENCEPHALOGRAPH	May 22, 1995	Substantially Equivalent	Nihon Kohden America, Inc.
K941551	THE VANGUARD SYSTEM	Jan 13, 1995	Substantially Equivalent	Cleveland Clinic Foundation
K934670	DG 3P SYSTEM	May 25, 1994	Substantially Equivalent	Medelec , Ltd.
K932407	CADWELL EASY WRITER AND EASY READER	Mar 22, 1994	Substantially Equivalent	Cadwell Laboratories, Inc.
K933233	CEEGRAPH, MODIFICATION	Mar 03, 1994	Substantially Equivalent	Bio-Logic Systems Corp.
K932842	SPACELABS MEDICAL MODEL 90481 EEG MODULE	Mar 02, 1994	Substantially Equivalent	Spacelabs Medical, Inc.
K933951	VIDEO EEG OPTION MODIFICATION	Feb 03, 1994	Substantially Equivalent	Esaote Biomedica Spa
K930080	E*NET NEUROMONITORING SYSTEM	Oct 19, 1993	Substantially Equivalent	Physiometrix, Inc.
K924179	EEG MODEL 24/32	Jun 22, 1993	Substantially Equivalent	Lama Engineering, Inc.
K921138	NICOLET ULTRASOM ACQUISITION STATION	May 14, 1993	Substantially Equivalent	Nicolet Instrument Corp.
K925838	TELEFACTOR D/EEG-32	Apr 30, 1993	Substantially Equivalent	Grass-Telefactor Product Group
K923894	YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH	Mar 10, 1993	Substantially Equivalent	Biosound, Inc.
K923860	THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR	Feb 04, 1993	Substantially Equivalent	Biosound, Inc.
K923950	THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH	Jan 26, 1993	Substantially Equivalent	Biosound, Inc.
K921927	NICOLET VOYAGEUR	Nov 05, 1992	Substantially Equivalent	Nicolet Instrument Corp.
K922548	MEDELEC 2110 AND 2114 EEG	Nov 03, 1992	Substantially Equivalent	Medelec Intl. Corp.
K921485	LA MONT VIDEO PATIENT MONITORING SYSTEM	Oct 22, 1992	Substantially Equivalent	Medical Systems Corp.
K920127	ELECTROENCEPHALOGRAPH RECORDING SYSTEM	Jun 10, 1992	Substantially Equivalent	Medelec Intl. Corp.
K915096	NEUROFAX EEG 5532	Mar 11, 1992	Substantially Equivalent	Nihon Kohden America, Inc.
K914571	NEUROTRAC II	Jan 30, 1992	Substantially Equivalent	Moberg Medical, Inc.
K910972	WALTER GRAPHTEK	Oct 02, 1991	Substantially Equivalent	Inomed Medizintechnik GmbH
K911229	PHOENIX DIGITAL EEG SYSTEM	Sep 30, 1991	Substantially Equivalent	Dantec Medical, Inc.
K910279	MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER	Sep 04, 1991	Substantially Equivalent	New England Medical Instruments, Inc.
K910945	HORIZON 2000 EEG MONITORING OPTION	Aug 15, 1991	Substantially Equivalent	Mennen Medical, Inc.
K905435	UNIQUANT	Jul 22, 1991	Substantially Equivalent	Neuroconcepts, Inc.
K904269	NEUROSEARCH-24 OR NRS-24	Jun 04, 1991	Substantially Equivalent	Lexicor Medical Technology, Inc.
K904763	MENTOR EEG SYSTEM	Apr 10, 1991	Substantially Equivalent	Oxford Medilog, Inc.
K902550	EEG-5400 SERIES	Mar 19, 1991	Substantially Equivalent	Nihon Kohden America, Inc.
K902752	NEURITOR 2001	Dec 04, 1990	Substantially Equivalent	Imexco General , Ltd.
K903004	EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH	Nov 15, 1990	Substantially Equivalent	Teca, Inc.
K901549	CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.	Oct 24, 1990	Substantially Equivalent	Cns, Inc.
K896942	SPACELABS MODEL 90480 EEG MODULE	Mar 08, 1990	Substantially Equivalent	Spacelabs, Inc.
K896666	P460, DG32 ELECTROENCEPHALOGRAPH	Feb 16, 1990	Substantially Equivalent	Teca, Inc.
K895125	CEEGRAPH	Dec 22, 1989	Substantially Equivalent	Bio-Logic Systems Corp.
K894044	ACTILLUME	Dec 22, 1989	Substantially Equivalent	Ambulatory Monitoring, Inc.
K894276	CADWELL FREEDOM EEG DEVICE	Sep 29, 1989	Substantially Equivalent	Cadwell Laboratories, Inc.
K890881	TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS	Mar 23, 1989	Substantially Equivalent	Teca, Inc.
K884537	AE-800PA EEG MODULE	Dec 29, 1988	Substantially Equivalent	Nihon Kohden America, Inc.
K883557	NEUROWAVE SYSTEM 2	Dec 16, 1988	Substantially Equivalent	Durden Enterprises, Inc.
K870815	KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265	Feb 01, 1988	Substantially Equivalent	Kontron Instruments, Inc.
K874796	MODEL EEG 4400 WITH OPTIONAL ACCESSORIES	Jan 19, 1988	Substantially Equivalent	Nihon Kohden America, Inc.
K873535	NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM	Oct 26, 1987	Substantially Equivalent	Nicolet Biomedical Instruments
K872183	AMBULATORY EEG PLAYBACK	Jul 21, 1987	Substantially Equivalent	Cadwell Laboratories, Inc.
K871500	MODEL 5000 AMBULATORY MONITORING SYSTEM	Jul 01, 1987	Substantially Equivalent	Oxford Medilog, Inc.
K870432	A1-A2 AMBULATORY EEG CASSETTE RECORDER	May 08, 1987	Substantially Equivalent	Grass-Telefactor Product Group
K870263	NEUROMAPPER 1620	Apr 10, 1987	Substantially Equivalent	Neuroscience, Inc.
K864928	BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER	Mar 31, 1987	Substantially Equivalent	Bio-Scan, Inc.
K863193	SENTINEL 4 EEG ANALYZER	Dec 02, 1986	Substantially Equivalent	Axon Systems, Inc.
K863124	MODEL 8 EEG PREAMPLIFIER	Nov 18, 1986	Substantially Equivalent	Micro Tronics Corp.
K863749	TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH	Oct 06, 1986	Substantially Equivalent	Teca, Inc.
K854663	NEUROFAX 7310 SERIES (EEG)	Aug 20, 1986	Substantially Equivalent	Nihon Kohden America, Inc.
K860456	MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM	Aug 11, 1986	Substantially Equivalent	Oxford Medilog, Inc.
K854030	WRIST ACTIGRAPH	Jun 25, 1986	Substantially Equivalent	Ambulatory Monitoring, Inc.
K854268	DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER	Mar 27, 1986	Substantially Equivalent	Del Mar Avionics
K851232	TECA MONTAGE II	Jun 13, 1985	Substantially Equivalent	Teca, Inc.
K850418	BUSHEL OFF-HEAD PREAMPLIFIER	Jun 13, 1985	Substantially Equivalent	Oxford Medilog, Inc.
K850259	ELECTROENCEPHALOGRAPH EEG	Apr 11, 1985	Substantially Equivalent	Nicolet Biomedical Instruments
K842784	CEREGROTRAC	Jan 10, 1985	Substantially Equivalent	Advanced Instruments, Inc.
K841653	DEL MAR AVIONICS 5509 NEURO-SCANNER	Dec 03, 1984	Substantially Equivalent	Del Mar Avionics
K842714	EEG-4300 W/OPTINAL ACCESS. EEG 4314 &	Sep 25, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K841684	BIO/SCAN BIOLOG CASSETTE RECORDER	Jun 07, 1984	Substantially Equivalent	Bio-Scan, Inc.
K841683	Q.P. PREAMPLIFIER SYS	Jun 07, 1984	Substantially Equivalent	Bio-Scan, Inc.
K831324	EEG 42/2P ELECTRO ENCEPHALOGRAPH	May 27, 1983	Substantially Equivalent	Nihon Kohden America, Inc.
K830295	MEDILOG 9000 SYSTEM	Mar 24, 1983	Substantially Equivalent	Oxford Medilog, Inc.
K823140	ELECTROENCEPHALOGRAPH	Dec 07, 1982	Substantially Equivalent	Nihon Kohden America, Inc.
K823116	NEUROTRAC	Dec 07, 1982	Substantially Equivalent	Interspec, Inc.
K822700	DEL MAR MODEL 5500 EEG SCANNER	Oct 04, 1982	Substantially Equivalent	Del Mar Avionics
K820779	OTE BIOMEDICAL #1296 - 16 CHAN. RECORD	Apr 26, 1982	Substantially Equivalent	Del Mar Avionics
K820605	OTE BIOMEDICA NEUROGRAPH 18	Mar 23, 1982	Substantially Equivalent	Del Mar Avionics
K820604	OTE BIOMEDICA NEUROGRAPH 9	Mar 23, 1982	Substantially Equivalent	Del Mar Avionics
K820603	OTE BIOMEDICA NEUROGRAPH 14	Mar 23, 1982	Substantially Equivalent	Del Mar Avionics
K820066	ELECTROENCEPHALOGRAPHS EEG-5208,5210	Feb 04, 1982	Substantially Equivalent	Nihon Kohden America, Inc.
K802887	MODEL EEG 4221	Dec 16, 1980	Substantially Equivalent	Nihon Kohden America, Inc.
K802296	MINGOGRAF EEG10	Oct 03, 1980	Substantially Equivalent	Siemens Corp.
K802292	MINGOGRAF EEG21	Oct 03, 1980	Substantially Equivalent	Siemens Corp.
K791234	MODEL EEG-4217 ELECTROENCEPHALOGRAPH	Sep 12, 1979	Substantially Equivalent	Nihon Kohden America, Inc.
K791233	MODEL EEG-4214 ELECTROENCEPHALOGRAPH	Sep 12, 1979	Substantially Equivalent	Nihon Kohden America, Inc.
K791150	ELECTROENCEPHALOGRAPHS MODELS 7209,7213	Sep 12, 1979	Substantially Equivalent	Nihon Kohden America, Inc.
K781129	ACCESSORY TO 4-24 RECORDER	Aug 31, 1978	Substantially Equivalent	Oxford Medilog, Inc.
K781041	ELECTROENCEPHALOGRAPH ACCUTRACE 100	Jun 28, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K781005	ELECTROENCEPHALOGRAPH ACCUTRATE 200	Jun 28, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K770246	ISOLATED EEG AMPLIFIER MODULE	Feb 14, 1977	Substantially Equivalent	Mennen Greatbatch Electonics