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Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
GXW
Echoencephalograph
2
Product Code
GXX
Block, Test, Ultrasonic Scanner Calibration
1
Product Code
GXY
Electrode, Cutaneous
2
Product Code
GXZ
Electrode, Needle
2
Product Code
GYA
Tester, Electrode/Lead, Electroencephalograph
1
Product Code
GXS
Monitor, Alpha
2
Product Code
GWE
Stimulator, Photic, Evoked Response
2
Product Code
GWF
Stimulator, Electrical, Evoked Response
2
Product Code
GWG
Endoscope, Neurological
2
Product Code
GWI
Discriminator, Two-Point
1
Product Code
GWJ
Stimulator, Auditory, Evoked Response
2
Product Code
GWK
Conditioner, Signal, Physiological
2
Product Code
GWL
Amplifier, Physiological Signal
2
Product Code
GWM
Device, Monitoring, Intracranial Pressure
2
Product Code
GWN
Nystagmograph
2
Product Code
GWQ
Full-Montage Standard Electroencephalograph
2
Product Code
K
23
3403
Flexset System
2
Cleared 510(K)
K
23
1366
Neuronaute Plus
2
Cleared 510(K)
K
22
1959
Q21
2
Cleared 510(K)
K
23
1457
SPARK Scan
2
Cleared 510(K)
K
22
1963
Cumulus Functional Neurophysiology Platform
2
Cleared 510(K)
K
23
0073
Okti
2
Cleared 510(K)
K
22
3644
Neuronaute with IceCap 2 & IceCap 2 Small
2
Cleared 510(K)
K
22
0056
iSyncWave
2
Cleared 510(K)
K
21
2788
Seer Home
2
Cleared 510(K)
K
21
3900
WAVi SCAN EEG System and Accessories
2
Cleared 510(K)
K
19
3159
NeuroAmp II, NeuroAmp II.5s
2
Cleared 510(K)
K
20
2334
Neuronaute
2
Cleared 510(K)
K
20
1819
Cadwell Apollo System
2
Cleared 510(K)
K
19
1492
Maxxi Position Sensor
2
Cleared 510(K)
K
19
1868
iCEWav Neuromonitoring Platform
2
Cleared 510(K)
K
19
2753
NeuralScan System
2
Cleared 510(K)
K
18
1466
Cadwell Zenith System
2
Cleared 510(K)
K
18
0269
Cadwell Apollo System
2
Cleared 510(K)
K
18
0290
Natus Brain Monitor Amplifier
2
Cleared 510(K)
K
17
2271
Trackit T4 EEG Amplifier
2
Cleared 510(K)
K
17
2735
WR19 System
2
Cleared 510(K)
K
18
0181
Natus Quantum
2
Cleared 510(K)
K
17
3460
NeuroEEG
2
Cleared 510(K)
K
17
1384
Micromed BRAIN QUICK system
2
Cleared 510(K)
K
17
0138
NEURONAUTE
2
Cleared 510(K)
K
17
1781
eVox System
2
Cleared 510(K)
K
17
1124
Nihon Kohden Wireless Input Unit WEE-1200
2
Cleared 510(K)
K
17
0441
ElectroTek
2
Cleared 510(K)
K
16
2681
Enobio Wireless EEG
2
Cleared 510(K)
K
16
3163
XLTEK EMU40EX EEG Headbox
2
Cleared 510(K)
K
16
2595
Trex_HD
2
Cleared 510(K)
K
15
0498
Discovery 24
2
Cleared 510(K)
K
14
3233
Mitsar-EEG
2
Cleared 510(K)
K
14
3440
Natus Quantum
2
Cleared 510(K)
K
13
1335
BWMINI EEG, BWMINIHST, BWMINI PSG
2
Cleared 510(K)
K
13
1266
TREZ_HD
2
Cleared 510(K)
K
13
3355
CADWELL FLEX EEG/PSG
2
Cleared 510(K)
K
13
1383
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
2
Cleared 510(K)
K
12
2196
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
2
Cleared 510(K)
K
12
0888
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
11
2817
MICROEEG SYSTEM
2
Cleared 510(K)
K
11
3117
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
2
Cleared 510(K)
K
11
2353
GEODESIC EEG MOBILE 100 (GEM 100)
2
Cleared 510(K)
K
11
2107
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
2
Cleared 510(K)
K
08
3577
HARMONIE SYSTEM
2
Cleared 510(K)
K
11
0376
PE-210AK SWITCH BOX
2
Cleared 510(K)
K
10
3129
ENTROPY EASYFIT SENSOR
2
Cleared 510(K)
K
10
1386
VIGILANT EEG MONITOR MODEL VIGILANT 2.0
2
Cleared 510(K)
K
10
0683
NEUROLINK IP MODEL: PK1117
2
Cleared 510(K)
K
09
3223
COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG
2
Cleared 510(K)
K
08
1741
NEUROLINK IP, MODEL PK1113
2
Cleared 510(K)
K
08
1151
COMPUMEDICS NEUVO
2
Cleared 510(K)
K
07
1109
SACS EEG WORKSTATION A7
2
Cleared 510(K)
K
06
1908
NICOLETONE SYSTEM V32 AMPLIFIER
2
Cleared 510(K)
K
05
3386
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
2
Cleared 510(K)
K
05
1825
COGNITRACE
2
Cleared 510(K)
K
04
2626
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
2
Cleared 510(K)
K
04
3309
GEODESIC PHOTOGRAMMETRY SYSTEM
2
Cleared 510(K)
K
04
2150
XLTEK TREX MODEL#10309
2
Cleared 510(K)
K
03
3399
GEODESIC EEG SYSTEM SERIES 100
2
Cleared 510(K)
K
04
0554
ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256
2
Cleared 510(K)
K
04
0360
EMU128S, MODEL EX-NW-128S
2
Cleared 510(K)
K
03
3978
ADAM
2
Cleared 510(K)
K
02
3771
SYNAMPS2
2
Cleared 510(K)
K
02
2785
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
2
Cleared 510(K)
K
02
1599
96 CHANNEL EEG HEADBOX MODEL EMU96
2
Cleared 510(K)
K
01
4147
80 CHANNEL EEG
2
Cleared 510(K)
K
01
4146
84 CHANNEL EEG
2
Cleared 510(K)
K
01
0997
PAM-RL
2
Cleared 510(K)
K
01
2079
GEODESIC EEG SYSTEM, MODEL 200
2
Cleared 510(K)
K
01
0697
UNIQUE AMBULATORY EEG
2
Cleared 510(K)
K
01
0669
NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1
2
Cleared 510(K)
K
01
1430
ACTIWARE-PLMS
2
Cleared 510(K)
K
01
0086
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
2
Cleared 510(K)
K
01
0089
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
2
Cleared 510(K)
K
01
0088
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
2
Cleared 510(K)
K
01
0084
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
2
Cleared 510(K)
K
01
0150
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
2
Cleared 510(K)
K
01
0091
EEG WITH VIDEO, MODEL EX-NW
2
Cleared 510(K)
K
00
2316
PHOENIX DIGITAL EEG
2
Cleared 510(K)
K
00
2570
BIO-LOGIC CEEGRAPH NETLINK
2
Cleared 510(K)
K
00
0919
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
2
Cleared 510(K)
K
00
1103
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
2
Cleared 510(K)
K
00
0898
EEG WITH VIDEO, MODEL EX-NW
2
Cleared 510(K)
K
99
1054
BRAVO MULTI-MODALITY SYSTEM
2
Cleared 510(K)
K
99
2410
ACTITRAC
2
Cleared 510(K)
K
99
1033
ACTIWATCH-SCORE
2
Cleared 510(K)
K
98
3533
ACTIWATCH
2
Cleared 510(K)
K
98
2479
EXCEL AMBULATORY EEG
2
Cleared 510(K)
K
98
0214
EXCEL NEURO WORKS
2
Cleared 510(K)
K
97
3883
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM
2
Cleared 510(K)
K
97
4495
NEUROAMP EEG AMPLIFIER
2
Cleared 510(K)
K
97
1329
CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
2
Cleared 510(K)
K
97
2202
DEEG-LITE
2
Cleared 510(K)
K
97
1331
SATELLITE
2
Cleared 510(K)
K
97
0942
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM
2
Cleared 510(K)
K
97
0703
GALILEO HALLEY
2
Cleared 510(K)
K
96
4280
DG NERVUS
2
Cleared 510(K)
K
96
1642
MEDILOG MR95
2
Cleared 510(K)
K
96
2447
EQUINOX DIGITAL EEG SYSTEM
2
Cleared 510(K)
K
96
2157
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM
2
Cleared 510(K)
K
95
4954
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
2
Cleared 510(K)
K
95
3449
MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS
2
Cleared 510(K)
K
94
6094
CADWELL EASY AMBULATORY EEG
2
Cleared 510(K)
K
95
1507
PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE
2
Cleared 510(K)
K
94
4678
NIHON KOHDEN ELECTROENCEPHALOGRAPH
2
Cleared 510(K)
K
94
1551
THE VANGUARD SYSTEM
2
Cleared 510(K)
K
93
4670
DG 3P SYSTEM
2
Cleared 510(K)
K
93
2407
CADWELL EASY WRITER AND EASY READER
2
Cleared 510(K)
K
93
3233
CEEGRAPH, MODIFICATION
2
Cleared 510(K)
K
93
2842
SPACELABS MEDICAL MODEL 90481 EEG MODULE
2
Cleared 510(K)
K
93
3951
VIDEO EEG OPTION MODIFICATION
2
Cleared 510(K)
K
93
0080
E*NET NEUROMONITORING SYSTEM
2
Cleared 510(K)
K
92
4179
EEG MODEL 24/32
2
Cleared 510(K)
K
92
1138
NICOLET ULTRASOM ACQUISITION STATION
2
Cleared 510(K)
K
92
5838
TELEFACTOR D/EEG-32
2
Cleared 510(K)
K
92
3894
YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH
2
Cleared 510(K)
K
92
3860
THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR
2
Cleared 510(K)
K
92
3950
THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH
2
Cleared 510(K)
K
92
1927
NICOLET VOYAGEUR
2
Cleared 510(K)
K
92
2548
MEDELEC 2110 AND 2114 EEG
2
Cleared 510(K)
K
92
1485
LA MONT VIDEO PATIENT MONITORING SYSTEM
2
Cleared 510(K)
K
92
0127
ELECTROENCEPHALOGRAPH RECORDING SYSTEM
2
Cleared 510(K)
K
91
5096
NEUROFAX EEG 5532
2
Cleared 510(K)
K
91
4571
NEUROTRAC II
2
Cleared 510(K)
K
91
0972
WALTER GRAPHTEK
2
Cleared 510(K)
K
91
1229
PHOENIX DIGITAL EEG SYSTEM
2
Cleared 510(K)
K
91
0279
MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER
2
Cleared 510(K)
K
91
0945
HORIZON 2000 EEG MONITORING OPTION
2
Cleared 510(K)
K
90
5435
UNIQUANT
2
Cleared 510(K)
K
90
4269
NEUROSEARCH-24 OR NRS-24
2
Cleared 510(K)
K
90
4763
MENTOR EEG SYSTEM
2
Cleared 510(K)
K
90
2550
EEG-5400 SERIES
2
Cleared 510(K)
K
90
2752
NEURITOR 2001
2
Cleared 510(K)
K
90
3004
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
2
Cleared 510(K)
K
90
1549
CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.
2
Cleared 510(K)
K
89
6942
SPACELABS MODEL 90480 EEG MODULE
2
Cleared 510(K)
K
89
6666
P460, DG32 ELECTROENCEPHALOGRAPH
2
Cleared 510(K)
K
89
5125
CEEGRAPH
2
Cleared 510(K)
K
89
4044
ACTILLUME
2
Cleared 510(K)
K
89
4276
CADWELL FREEDOM EEG DEVICE
2
Cleared 510(K)
K
89
0881
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
2
Cleared 510(K)
K
88
4537
AE-800PA EEG MODULE
2
Cleared 510(K)
K
88
3557
NEUROWAVE SYSTEM 2
2
Cleared 510(K)
K
87
0815
KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265
2
Cleared 510(K)
K
87
4796
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
2
Cleared 510(K)
K
87
3535
NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM
2
Cleared 510(K)
K
87
2183
AMBULATORY EEG PLAYBACK
2
Cleared 510(K)
K
87
1500
MODEL 5000 AMBULATORY MONITORING SYSTEM
2
Cleared 510(K)
K
87
0432
A1-A2 AMBULATORY EEG CASSETTE RECORDER
2
Cleared 510(K)
K
87
0263
NEUROMAPPER 1620
2
Cleared 510(K)
K
86
4928
BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER
2
Cleared 510(K)
K
86
3193
SENTINEL 4 EEG ANALYZER
2
Cleared 510(K)
K
86
3124
MODEL 8 EEG PREAMPLIFIER
2
Cleared 510(K)
K
86
3749
TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH
2
Cleared 510(K)
K
85
4663
NEUROFAX 7310 SERIES (EEG)
2
Cleared 510(K)
K
86
0456
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
2
Cleared 510(K)
K
85
4030
WRIST ACTIGRAPH
2
Cleared 510(K)
K
85
4268
DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
2
Cleared 510(K)
K
85
1232
TECA MONTAGE II
2
Cleared 510(K)
K
85
0418
BUSHEL OFF-HEAD PREAMPLIFIER
2
Cleared 510(K)
K
85
0259
ELECTROENCEPHALOGRAPH EEG
2
Cleared 510(K)
K
84
2784
CEREGROTRAC
2
Cleared 510(K)
K
84
1653
DEL MAR AVIONICS 5509 NEURO-SCANNER
2
Cleared 510(K)
K
84
2714
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
2
Cleared 510(K)
K
84
1684
BIO/SCAN BIOLOG CASSETTE RECORDER
2
Cleared 510(K)
K
84
1683
Q.P. PREAMPLIFIER SYS
2
Cleared 510(K)
K
83
1324
EEG 42/2P ELECTRO ENCEPHALOGRAPH
2
Cleared 510(K)
K
83
0295
MEDILOG 9000 SYSTEM
2
Cleared 510(K)
K
82
3140
ELECTROENCEPHALOGRAPH
2
Cleared 510(K)
K
82
3116
NEUROTRAC
2
Cleared 510(K)
K
82
2700
DEL MAR MODEL 5500 EEG SCANNER
2
Cleared 510(K)
K
82
0779
OTE BIOMEDICAL #1296 - 16 CHAN. RECORD
2
Cleared 510(K)
K
82
0604
OTE BIOMEDICA NEUROGRAPH 9
2
Cleared 510(K)
K
82
0605
OTE BIOMEDICA NEUROGRAPH 18
2
Cleared 510(K)
K
82
0603
OTE BIOMEDICA NEUROGRAPH 14
2
Cleared 510(K)
K
82
0066
ELECTROENCEPHALOGRAPHS EEG-5208,5210
2
Cleared 510(K)
K
80
2887
MODEL EEG 4221
2
Cleared 510(K)
K
80
2296
MINGOGRAF EEG10
2
Cleared 510(K)
K
80
2292
MINGOGRAF EEG21
2
Cleared 510(K)
K
79
1234
MODEL EEG-4217 ELECTROENCEPHALOGRAPH
2
Cleared 510(K)
K
79
1233
MODEL EEG-4214 ELECTROENCEPHALOGRAPH
2
Cleared 510(K)
K
79
1150
ELECTROENCEPHALOGRAPHS MODELS 7209,7213
2
Cleared 510(K)
K
78
1129
ACCESSORY TO 4-24 RECORDER
2
Cleared 510(K)
K
78
1041
ELECTROENCEPHALOGRAPH ACCUTRACE 100
2
Cleared 510(K)
K
78
1005
ELECTROENCEPHALOGRAPH ACCUTRATE 200
2
Cleared 510(K)
K
77
0246
ISOLATED EEG AMPLIFIER MODULE
2
Cleared 510(K)
GWR
Generator, Electroencephalograph Test Signal
1
Product Code
GWS
Analyzer, Spectrum, Electroencephalogram Signal
1
Product Code
GWW
Ataxiagraph
1
Product Code
GWX
Fork, Tuning
1
Product Code
GWY
Pinwheel
1
Product Code
GWZ
Percussor
1
Product Code
GXB
Esthesiometer
1
Product Code
GYB
Media, Electroconductive
2
Product Code
GYC
Electrode, Cortical
2
Product Code
GYD
Transducer, Tremor
2
Product Code
GYE
Encephalogram Telemetry System
2
Product Code
GZK
Electrode, Nasopharyngeal
2
Product Code
GZL
Electrode, Depth
2
Product Code
GZM
Analyzer, Rigidity
2
Product Code
GZN
Rheoencephalograph
3
Product Code
GZO
Device, Galvanic Skin Response Measurement
2
Product Code
GZP
Stimulator, Mechanical, Evoked Response
2
Product Code
HCJ
Device, Skin Potential Measurement
2
Product Code
HCS
Device, Temperature Measurement, Direct Contact, Powered
2
Product Code
JXE
Device, Nerve Conduction Velocity Measurement
2
Product Code
JXF
Plethysmograph, Ocular
3
Product Code
LLN
Device, Vibration Threshold Measurement
1
Product Code
LQW
Test, Temperature Discrimination
1
Product Code
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
2
Product Code
NTU
Evoked Potential Stimulator, Thermal
2
Product Code
OLT
Non-Normalizing Quantitative Electroencephalograph Software
2
Product Code
OLU
Normalizing Quantitative Electroencephalograph Software
2
Product Code
OLV
Standard Polysomnograph With Electroencephalograph
2
Product Code
OLW
Index-Generating Electroencephalograph Software
2
Product Code
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
2
Product Code
OLY
Magnetoencephalograph
2
Product Code
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
2
Product Code
OMA
Amplitude-Integrated Electroencephalograph
2
Product Code
OMB
Automatic Event Detection Software For Full-Montage Electroencephalograph
2
Product Code
OMC
Reduced- Montage Standard Electroencephalograph
2
Product Code
ORT
Burst Suppression Detection Software For Electroencephalograph
2
Product Code
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
2
Product Code
PKQ
Computerized Cognitive Assessment Aid
2
Product Code
PNA
Evoked Photon Image Capture Device
1
Product Code
POM
Computerized Cognitive Assessment Aid For Concussion
2
Product Code
POP
Cranial Motion Measurement Device
2
Product Code
POS
Physiological Signal Based Seizure Monitoring System
2
Product Code
PSP
Intracranial Pressure & Temperature Monitoring Kit
2
Product Code
PTB
Ataxiagraph With Interpretive Software
1
Product Code
PTY
Computerized Cognitive Assessment Aid, Exempt
2
Product Code
PVP
Neurological Test Kit
1
Product Code
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
2
Product Code
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
2
Product Code
OPT
Infrared Hematoma Detector
2
Product Code
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
NE
/
subpart-b—neurological-diagnostic-devices
/
GWQ
/
K820066
View Source
ELECTROENCEPHALOGRAPHS EEG-5208,5210
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
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510(k) Number
K820066
510(k) Type
Traditional
Applicant
NIHON KOHDEN AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/1982
Days to Decision
24 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
GXW
Echoencephalograph
GXX
Block, Test, Ultrasonic Scanner Calibration
GXY
Electrode, Cutaneous
GXZ
Electrode, Needle
GYA
Tester, Electrode/Lead, Electroencephalograph
GXS
Monitor, Alpha
GWE
Stimulator, Photic, Evoked Response
GWF
Stimulator, Electrical, Evoked Response
GWG
Endoscope, Neurological
GWI
Discriminator, Two-Point
GWJ
Stimulator, Auditory, Evoked Response
GWK
Conditioner, Signal, Physiological
GWL
Amplifier, Physiological Signal
GWM
Device, Monitoring, Intracranial Pressure
GWN
Nystagmograph
GWQ
Full-Montage Standard Electroencephalograph
K
23
3403
Flexset System
K
23
1366
Neuronaute Plus
K
22
1959
Q21
K
23
1457
SPARK Scan
K
22
1963
Cumulus Functional Neurophysiology Platform
K
23
0073
Okti
K
22
3644
Neuronaute with IceCap 2 & IceCap 2 Small
K
22
0056
iSyncWave
K
21
2788
Seer Home
K
21
3900
WAVi SCAN EEG System and Accessories
K
19
3159
NeuroAmp II, NeuroAmp II.5s
K
20
2334
Neuronaute
K
20
1819
Cadwell Apollo System
K
19
1492
Maxxi Position Sensor
K
19
1868
iCEWav Neuromonitoring Platform
K
19
2753
NeuralScan System
K
18
1466
Cadwell Zenith System
K
18
0269
Cadwell Apollo System
K
18
0290
Natus Brain Monitor Amplifier
K
17
2271
Trackit T4 EEG Amplifier
K
17
2735
WR19 System
K
18
0181
Natus Quantum
K
17
3460
NeuroEEG
K
17
1384
Micromed BRAIN QUICK system
K
17
0138
NEURONAUTE
K
17
1781
eVox System
K
17
1124
Nihon Kohden Wireless Input Unit WEE-1200
K
17
0441
ElectroTek
K
16
2681
Enobio Wireless EEG
K
16
3163
XLTEK EMU40EX EEG Headbox
K
16
2595
Trex_HD
K
15
0498
Discovery 24
K
14
3233
Mitsar-EEG
K
14
3440
Natus Quantum
K
13
1335
BWMINI EEG, BWMINIHST, BWMINI PSG
K
13
1266
TREZ_HD
K
13
3355
CADWELL FLEX EEG/PSG
K
13
1383
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
K
12
2196
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
K
12
0888
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
K
11
2817
MICROEEG SYSTEM
K
11
3117
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K
11
2353
GEODESIC EEG MOBILE 100 (GEM 100)
K
11
2107
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
K
08
3577
HARMONIE SYSTEM
K
11
0376
PE-210AK SWITCH BOX
K
10
3129
ENTROPY EASYFIT SENSOR
K
10
1386
VIGILANT EEG MONITOR MODEL VIGILANT 2.0
K
10
0683
NEUROLINK IP MODEL: PK1117
K
09
3223
COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG
K
08
1741
NEUROLINK IP, MODEL PK1113
K
08
1151
COMPUMEDICS NEUVO
K
07
1109
SACS EEG WORKSTATION A7
K
06
1908
NICOLETONE SYSTEM V32 AMPLIFIER
K
05
3386
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
K
05
1825
COGNITRACE
K
04
2626
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
K
04
3309
GEODESIC PHOTOGRAMMETRY SYSTEM
K
04
2150
XLTEK TREX MODEL#10309
K
03
3399
GEODESIC EEG SYSTEM SERIES 100
K
04
0554
ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256
K
04
0360
EMU128S, MODEL EX-NW-128S
K
03
3978
ADAM
K
02
3771
SYNAMPS2
K
02
2785
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
K
02
1599
96 CHANNEL EEG HEADBOX MODEL EMU96
K
01
4147
80 CHANNEL EEG
K
01
4146
84 CHANNEL EEG
K
01
0997
PAM-RL
K
01
2079
GEODESIC EEG SYSTEM, MODEL 200
K
01
0697
UNIQUE AMBULATORY EEG
K
01
0669
NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1
K
01
1430
ACTIWARE-PLMS
K
01
0086
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
K
01
0089
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
K
01
0088
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
K
01
0084
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
K
01
0150
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K
01
0091
EEG WITH VIDEO, MODEL EX-NW
K
00
2316
PHOENIX DIGITAL EEG
K
00
2570
BIO-LOGIC CEEGRAPH NETLINK
K
00
0919
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
K
00
1103
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
K
00
0898
EEG WITH VIDEO, MODEL EX-NW
K
99
1054
BRAVO MULTI-MODALITY SYSTEM
K
99
2410
ACTITRAC
K
99
1033
ACTIWATCH-SCORE
K
98
3533
ACTIWATCH
K
98
2479
EXCEL AMBULATORY EEG
K
98
0214
EXCEL NEURO WORKS
K
97
3883
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM
K
97
4495
NEUROAMP EEG AMPLIFIER
K
97
1329
CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
K
97
2202
DEEG-LITE
K
97
1331
SATELLITE
K
97
0942
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM
K
97
0703
GALILEO HALLEY
K
96
4280
DG NERVUS
K
96
1642
MEDILOG MR95
K
96
2447
EQUINOX DIGITAL EEG SYSTEM
K
96
2157
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM
K
95
4954
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
K
95
3449
MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS
K
94
6094
CADWELL EASY AMBULATORY EEG
K
95
1507
PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE
K
94
4678
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K
94
1551
THE VANGUARD SYSTEM
K
93
4670
DG 3P SYSTEM
K
93
2407
CADWELL EASY WRITER AND EASY READER
K
93
3233
CEEGRAPH, MODIFICATION
K
93
2842
SPACELABS MEDICAL MODEL 90481 EEG MODULE
K
93
3951
VIDEO EEG OPTION MODIFICATION
K
93
0080
E*NET NEUROMONITORING SYSTEM
K
92
4179
EEG MODEL 24/32
K
92
1138
NICOLET ULTRASOM ACQUISITION STATION
K
92
5838
TELEFACTOR D/EEG-32
K
92
3894
YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH
K
92
3860
THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR
K
92
3950
THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH
K
92
1927
NICOLET VOYAGEUR
K
92
2548
MEDELEC 2110 AND 2114 EEG
K
92
1485
LA MONT VIDEO PATIENT MONITORING SYSTEM
K
92
0127
ELECTROENCEPHALOGRAPH RECORDING SYSTEM
K
91
5096
NEUROFAX EEG 5532
K
91
4571
NEUROTRAC II
K
91
0972
WALTER GRAPHTEK
K
91
1229
PHOENIX DIGITAL EEG SYSTEM
K
91
0279
MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER
K
91
0945
HORIZON 2000 EEG MONITORING OPTION
K
90
5435
UNIQUANT
K
90
4269
NEUROSEARCH-24 OR NRS-24
K
90
4763
MENTOR EEG SYSTEM
K
90
2550
EEG-5400 SERIES
K
90
2752
NEURITOR 2001
K
90
3004
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K
90
1549
CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.
K
89
6942
SPACELABS MODEL 90480 EEG MODULE
K
89
6666
P460, DG32 ELECTROENCEPHALOGRAPH
K
89
5125
CEEGRAPH
K
89
4044
ACTILLUME
K
89
4276
CADWELL FREEDOM EEG DEVICE
K
89
0881
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
K
88
4537
AE-800PA EEG MODULE
K
88
3557
NEUROWAVE SYSTEM 2
K
87
0815
KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265
K
87
4796
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
K
87
3535
NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM
K
87
2183
AMBULATORY EEG PLAYBACK
K
87
1500
MODEL 5000 AMBULATORY MONITORING SYSTEM
K
87
0432
A1-A2 AMBULATORY EEG CASSETTE RECORDER
K
87
0263
NEUROMAPPER 1620
K
86
4928
BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER
K
86
3193
SENTINEL 4 EEG ANALYZER
K
86
3124
MODEL 8 EEG PREAMPLIFIER
K
86
3749
TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH
K
85
4663
NEUROFAX 7310 SERIES (EEG)
K
86
0456
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K
85
4030
WRIST ACTIGRAPH
K
85
4268
DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
K
85
1232
TECA MONTAGE II
K
85
0418
BUSHEL OFF-HEAD PREAMPLIFIER
K
85
0259
ELECTROENCEPHALOGRAPH EEG
K
84
2784
CEREGROTRAC
K
84
1653
DEL MAR AVIONICS 5509 NEURO-SCANNER
K
84
2714
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
K
84
1684
BIO/SCAN BIOLOG CASSETTE RECORDER
K
84
1683
Q.P. PREAMPLIFIER SYS
K
83
1324
EEG 42/2P ELECTRO ENCEPHALOGRAPH
K
83
0295
MEDILOG 9000 SYSTEM
K
82
3140
ELECTROENCEPHALOGRAPH
K
82
3116
NEUROTRAC
K
82
2700
DEL MAR MODEL 5500 EEG SCANNER
K
82
0779
OTE BIOMEDICAL #1296 - 16 CHAN. RECORD
K
82
0604
OTE BIOMEDICA NEUROGRAPH 9
K
82
0605
OTE BIOMEDICA NEUROGRAPH 18
K
82
0603
OTE BIOMEDICA NEUROGRAPH 14
K
82
0066
ELECTROENCEPHALOGRAPHS EEG-5208,5210
K
80
2887
MODEL EEG 4221
K
80
2296
MINGOGRAF EEG10
K
80
2292
MINGOGRAF EEG21
K
79
1234
MODEL EEG-4217 ELECTROENCEPHALOGRAPH
K
79
1233
MODEL EEG-4214 ELECTROENCEPHALOGRAPH
K
79
1150
ELECTROENCEPHALOGRAPHS MODELS 7209,7213
K
78
1129
ACCESSORY TO 4-24 RECORDER
K
78
1041
ELECTROENCEPHALOGRAPH ACCUTRACE 100
K
78
1005
ELECTROENCEPHALOGRAPH ACCUTRATE 200
K
77
0246
ISOLATED EEG AMPLIFIER MODULE
GWR
Generator, Electroencephalograph Test Signal
GWS
Analyzer, Spectrum, Electroencephalogram Signal
GWW
Ataxiagraph
GWX
Fork, Tuning
GWY
Pinwheel
GWZ
Percussor
GXB
Esthesiometer
GYB
Media, Electroconductive
GYC
Electrode, Cortical
GYD
Transducer, Tremor
GYE
Encephalogram Telemetry System
GZK
Electrode, Nasopharyngeal
GZL
Electrode, Depth
GZM
Analyzer, Rigidity
GZN
Rheoencephalograph
GZO
Device, Galvanic Skin Response Measurement
GZP
Stimulator, Mechanical, Evoked Response
HCJ
Device, Skin Potential Measurement
HCS
Device, Temperature Measurement, Direct Contact, Powered
JXE
Device, Nerve Conduction Velocity Measurement
JXF
Plethysmograph, Ocular
LLN
Device, Vibration Threshold Measurement
LQW
Test, Temperature Discrimination
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
NTU
Evoked Potential Stimulator, Thermal
OLT
Non-Normalizing Quantitative Electroencephalograph Software
OLU
Normalizing Quantitative Electroencephalograph Software
OLV
Standard Polysomnograph With Electroencephalograph
OLW
Index-Generating Electroencephalograph Software
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
OLY
Magnetoencephalograph
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
OMA
Amplitude-Integrated Electroencephalograph
OMB
Automatic Event Detection Software For Full-Montage Electroencephalograph
OMC
Reduced- Montage Standard Electroencephalograph
ORT
Burst Suppression Detection Software For Electroencephalograph
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
PKQ
Computerized Cognitive Assessment Aid
PNA
Evoked Photon Image Capture Device
POM
Computerized Cognitive Assessment Aid For Concussion
POP
Cranial Motion Measurement Device
POS
Physiological Signal Based Seizure Monitoring System
PSP
Intracranial Pressure & Temperature Monitoring Kit
PTB
Ataxiagraph With Interpretive Software
PTY
Computerized Cognitive Assessment Aid, Exempt
PVP
Neurological Test Kit
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
OPT
Infrared Hematoma Detector
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—neurological-diagnostic-devices
/
GWQ
/
K820066
View Source
ELECTROENCEPHALOGRAPHS EEG-5208,5210
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K820066
510(k) Type
Traditional
Applicant
NIHON KOHDEN AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/1982
Days to Decision
24 days