FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Miscellaneous
Miscellaneous
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
K
24
2345
Delphi Stimulator
2
Cleared 510(K)
K
23
4092
SafeOp 3: Neural Informatix Systeem
2
Cleared 510(K)
K
23
4080
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
2
Cleared 510(K)
K
23
3292
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
2
Cleared 510(K)
K
23
0415
Cadwell Guardian
2
Cleared 510(K)
K
21
3849
SafeOp 2: Neural Informatix System
2
Cleared 510(K)
K
21
2166
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
2
Cleared 510(K)
K
19
2823
MEGA-TMS
2
Cleared 510(K)
K
19
0703
Neuro-IOM system with Neuro-IOM.NET software
2
Cleared 510(K)
K
20
0759
NIM Vital, Nerve Integrity Monitor
2
Cleared 510(K)
K
18
2542
The EPAD 2 System
2
Cleared 510(K)
K
17
0677
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
2
Cleared 510(K)
K
16
2873
MEP Monitor
2
Cleared 510(K)
K
16
2199
Cascade IOMAX Intraoperative Monitor
2
Cleared 510(K)
K
16
0280
MagPro R20
2
Cleared 510(K)
K
15
0220
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
2
Cleared 510(K)
K
14
2624
Neuromaster G1 MEE200
2
Cleared 510(K)
K
13
2616
EPAD
2
Cleared 510(K)
K
13
0403
MAGSTIM DOUBLE 70-2 COIL
2
Cleared 510(K)
K
12
3843
NEUROEPG SYSTEM
2
Cleared 510(K)
K
13
0346
SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION
2
Cleared 510(K)
K
12
0397
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
2
Cleared 510(K)
K
11
2881
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
2
Cleared 510(K)
K
12
0979
CAREFUSION NICOLET EDX
2
Cleared 510(K)
K
11
2052
CAREFUSION NICOLET EDX
2
Cleared 510(K)
K
11
1647
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
2
Cleared 510(K)
K
11
0140
NEUROVISION NERVE LOCATOR MONITOR
2
Cleared 510(K)
K
09
3304
PROTEKTOR 32
2
Cleared 510(K)
K
09
4054
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
09
1940
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
2
Cleared 510(K)
K
09
1457
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
2
Cleared 510(K)
K
08
3371
NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
2
Cleared 510(K)
K
09
0298
NUVASIVE NEURO VISION SYSTEM
2
Cleared 510(K)
K
08
2614
EVOX ELECTRO DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
08
3124
NIM 3.0
2
Cleared 510(K)
K
08
0499
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
2
Cleared 510(K)
K
07
1969
SEN-4100 ELECTRIC STIMULATOR
2
Cleared 510(K)
K
07
2343
NEUROVISION JJB SYSTEM
2
Cleared 510(K)
K
07
1821
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
2
Cleared 510(K)
K
06
2765
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
2
Cleared 510(K)
K
06
1639
ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
2
Cleared 510(K)
K
06
1645
MAGPRO, MODEL R30
2
Cleared 510(K)
K
06
0847
MAGSTIM 200-2
2
Cleared 510(K)
K
06
1113
ORTHOMON
2
Cleared 510(K)
K
05
1864
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
2
Cleared 510(K)
K
05
1357
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
2
Cleared 510(K)
K
05
1178
MEE-1000A NEUROMASTER
2
Cleared 510(K)
K
05
0798
ECLIPSE NEUROLOGICAL WORKSTATION
2
Cleared 510(K)
K
05
1384
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
2
Cleared 510(K)
K
03
0526
PEDIGUARD NERVE DETECTOR SYSTEM
2
Cleared 510(K)
K
04
2350
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
2
Cleared 510(K)
K
04
0358
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
2
Cleared 510(K)
K
03
1930
HIGH SPEED EMG MODULE
2
Cleared 510(K)
K
03
2741
EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
2
Cleared 510(K)
K
02
0400
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
2
Cleared 510(K)
K
01
0092
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
2
Cleared 510(K)
K
01
0090
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
2
Cleared 510(K)
K
01
0087
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
2
Cleared 510(K)
K
00
2969
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
2
Cleared 510(K)
K
00
2773
NEUROMAP WITH NEURO 100
2
Cleared 510(K)
K
00
0963
DA VINCHI EEG AND EMG/EP SYSTEMS
2
Cleared 510(K)
K
00
1101
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
2
Cleared 510(K)
K
99
2911
MAGSTIM RAPID
2
Cleared 510(K)
K
99
1899
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
2
Cleared 510(K)
K
99
2313
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
2
Cleared 510(K)
K
98
1405
SYNERGY LT
2
Cleared 510(K)
K
98
0866
MEDI-DX 7000 CPT WITH AMREX ELECTRODES
2
Cleared 510(K)
K
97
1740
AMPLAID MK12
2
Cleared 510(K)
K
97
2959
AMPLAID MK22
2
Cleared 510(K)
K
97
1819
EPOCH 2000 NEUROLOGICAL WORKSTATION
2
Cleared 510(K)
K
96
5065
TECA. MILLENNIUM
2
Cleared 510(K)
K
96
3662
GALILEO EVOKED POTENTIALRE
2
Cleared 510(K)
K
96
2457
TWO-CHANNEL PREAMPLIFIER
2
Cleared 510(K)
K
96
2458
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
2
Cleared 510(K)
K
96
2455
FOUR-CHANNEL PREAMPLIFIER
2
Cleared 510(K)
K
93
2994
EVOKED POTENTIAL SYSTEM-1.0
2
Cleared 510(K)
K
96
0170
ELECTROENCEPHALOGRAPH (EEG)
2
Cleared 510(K)
K
95
5257
SS102 DUAL CHANNEL SEP STIMULATOR
2
Cleared 510(K)
K
95
2294
NEURONET
2
Cleared 510(K)
K
94
4547
DANTEC KEYPOINT
2
Cleared 510(K)
K
95
0208
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
2
Cleared 510(K)
K
93
1923
DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)
2
Cleared 510(K)
K
92
6516
DANTEC MAGNETIC STIMULATOR MAGPRO
2
Cleared 510(K)
K
93
1428
CADWELL 6200 A
2
Cleared 510(K)
K
92
4723
CADWELL SIERRA
2
Cleared 510(K)
K
92
4127
DANTEC EVOLUTION
2
Cleared 510(K)
K
92
3303
SAPPHIRE PREMIERE
2
Cleared 510(K)
K
92
3315
NICOLET ARK SYSTEM
2
Cleared 510(K)
K
91
2685
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
2
Cleared 510(K)
K
91
5652
NICOLET PORATBLE SPIRIT SYSTEM
2
Cleared 510(K)
K
91
2775
SAPPHIRE 4ME EMG/EP SYSTEM
2
Cleared 510(K)
K
90
5059
HIGH SPEED MAGNETIC STIMULATOR
2
Cleared 510(K)
K
90
2607
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
2
Cleared 510(K)
K
90
3731
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
2
Cleared 510(K)
K
89
4560
QSI 9000
2
Cleared 510(K)
K
90
0482
SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG
2
Cleared 510(K)
K
89
6567
CANTATA EMG/EVOKED RESPONSE SYSTEM
2
Cleared 510(K)
K
89
4608
MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM
2
Cleared 510(K)
K
89
0274
MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR
2
Cleared 510(K)
K
88
5246
ADVANTAGE
2
Cleared 510(K)
K
88
4870
TECA/MEDELEC 'CONCEPT' P420
2
Cleared 510(K)
K
88
3340
NEURAL MAGNETIC STIMULATOR, THE D190
2
Cleared 510(K)
K
88
1915
DANTEC MAGNETIC STIMULATOR
2
Cleared 510(K)
K
88
0088
CADWELL EXCEL
2
Cleared 510(K)
K
87
0567
EVOPORT 300
2
Cleared 510(K)
K
87
1964
SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
2
Cleared 510(K)
K
87
2106
DANTEC COUNTERPOINT
2
Cleared 510(K)
K
87
1338
NOVAMETRIX MODEL 200 MAGSTIM
2
Cleared 510(K)
K
86
3175
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
2
Cleared 510(K)
K
86
2690
TRAVELER LT
2
Cleared 510(K)
K
86
1900
LIFESCAN EVOKED POTENTIAL SYSTEM
2
Cleared 510(K)
K
86
0968
TM-3400, NOMAD (MODIFIED)
2
Cleared 510(K)
K
85
5232
SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
2
Cleared 510(K)
K
86
0903
TM-3600 A NEURODIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
86
0240
CNS-EP SYSTEM AND EP 1.0 SOFTWARE
2
Cleared 510(K)
K
85
1300
NEUROPACK 8, MEE-4108
2
Cleared 510(K)
K
84
4992
BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
2
Cleared 510(K)
K
85
0109
NOMAD TM-3400
2
Cleared 510(K)
K
84
3815
EVOMATIC 8000/4000
2
Cleared 510(K)
K
84
4707
QUANTUM 84
2
Cleared 510(K)
K
84
3712
AUDIT TM V
2
Cleared 510(K)
K
84
2543
EVOKED POTENTIAL SYS
2
Cleared 510(K)
K
84
3464
SIEGEN NEUROSCOPE
2
Cleared 510(K)
K
84
3253
EMG/NCV & EVOKED RESPONSE, DESIGN W/
2
Cleared 510(K)
K
83
1896
COMPACT FOUR
2
Cleared 510(K)
K
83
0771
CADWELL 8400
2
Cleared 510(K)
K
82
2744
#ST10 PROGR. EVOKED RESPONSE STIMULATOR
2
Cleared 510(K)
K
82
2396
THE 3500
2
Cleared 510(K)
K
82
2214
CADWELL 7400
2
Cleared 510(K)
K
82
0908
TECA MODEL SENSOR ER 94
2
Cleared 510(K)
K
82
0414
UNIVERSAL TESTING & ANALYSIS SYSTEMS
2
Cleared 510(K)
K
81
1848
MODEL SIX BEAM SYSTEM
2
Cleared 510(K)
K
81
0482
SOMATOSENSORY STIMULATOR
2
Cleared 510(K)
K
81
0560
TN-3000 EVOKED RESPONSE SYSTEM
2
Cleared 510(K)
K
78
1704
STIMULATOR, TN-3001 SOMATOSENSORY
2
Cleared 510(K)
K
78
0539
STIMULATOR MODEL 8021
2
Cleared 510(K)
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
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 6 December 2024 at 11:05 pm
NE
/
subpart-b—neurological-diagnostic-devices
/
GWF
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K862690
View Source
TRAVELER LT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862690
510(k) Type
Traditional
Applicant
BIO-LOGIC SYSTEMS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/1986
Days to Decision
133 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
K
24
2345
Delphi Stimulator
K
23
4092
SafeOp 3: Neural Informatix Systeem
K
23
4080
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K
23
3292
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K
23
0415
Cadwell Guardian
K
21
3849
SafeOp 2: Neural Informatix System
K
21
2166
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K
19
2823
MEGA-TMS
K
19
0703
Neuro-IOM system with Neuro-IOM.NET software
K
20
0759
NIM Vital, Nerve Integrity Monitor
K
18
2542
The EPAD 2 System
K
17
0677
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
K
16
2873
MEP Monitor
K
16
2199
Cascade IOMAX Intraoperative Monitor
K
16
0280
MagPro R20
K
15
0220
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
K
14
2624
Neuromaster G1 MEE200
K
13
2616
EPAD
K
13
0403
MAGSTIM DOUBLE 70-2 COIL
K
12
3843
NEUROEPG SYSTEM
K
13
0346
SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION
K
12
0397
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
K
11
2881
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
K
12
0979
CAREFUSION NICOLET EDX
K
11
2052
CAREFUSION NICOLET EDX
K
11
1647
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
K
11
0140
NEUROVISION NERVE LOCATOR MONITOR
K
09
3304
PROTEKTOR 32
K
09
4054
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
K
09
1940
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
K
09
1457
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
K
08
3371
NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
K
09
0298
NUVASIVE NEURO VISION SYSTEM
K
08
2614
EVOX ELECTRO DIAGNOSTIC DEVICE
K
08
3124
NIM 3.0
K
08
0499
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
K
07
1969
SEN-4100 ELECTRIC STIMULATOR
K
07
2343
NEUROVISION JJB SYSTEM
K
07
1821
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
K
06
2765
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
K
06
1639
ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
K
06
1645
MAGPRO, MODEL R30
K
06
0847
MAGSTIM 200-2
K
06
1113
ORTHOMON
K
05
1864
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
K
05
1357
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
K
05
1178
MEE-1000A NEUROMASTER
K
05
0798
ECLIPSE NEUROLOGICAL WORKSTATION
K
05
1384
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K
03
0526
PEDIGUARD NERVE DETECTOR SYSTEM
K
04
2350
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
K
04
0358
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
K
03
1930
HIGH SPEED EMG MODULE
K
03
2741
EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
K
02
0400
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
K
01
0092
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
K
01
0090
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
K
01
0087
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
K
00
2969
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
K
00
2773
NEUROMAP WITH NEURO 100
K
00
0963
DA VINCHI EEG AND EMG/EP SYSTEMS
K
00
1101
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
K
99
2911
MAGSTIM RAPID
K
99
1899
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
K
99
2313
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
K
98
1405
SYNERGY LT
K
98
0866
MEDI-DX 7000 CPT WITH AMREX ELECTRODES
K
97
1740
AMPLAID MK12
K
97
2959
AMPLAID MK22
K
97
1819
EPOCH 2000 NEUROLOGICAL WORKSTATION
K
96
5065
TECA. MILLENNIUM
K
96
3662
GALILEO EVOKED POTENTIALRE
K
96
2457
TWO-CHANNEL PREAMPLIFIER
K
96
2458
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
K
96
2455
FOUR-CHANNEL PREAMPLIFIER
K
93
2994
EVOKED POTENTIAL SYSTEM-1.0
K
96
0170
ELECTROENCEPHALOGRAPH (EEG)
K
95
5257
SS102 DUAL CHANNEL SEP STIMULATOR
K
95
2294
NEURONET
K
94
4547
DANTEC KEYPOINT
K
95
0208
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
K
93
1923
DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)
K
92
6516
DANTEC MAGNETIC STIMULATOR MAGPRO
K
93
1428
CADWELL 6200 A
K
92
4723
CADWELL SIERRA
K
92
4127
DANTEC EVOLUTION
K
92
3303
SAPPHIRE PREMIERE
K
92
3315
NICOLET ARK SYSTEM
K
91
2685
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K
91
5652
NICOLET PORATBLE SPIRIT SYSTEM
K
91
2775
SAPPHIRE 4ME EMG/EP SYSTEM
K
90
5059
HIGH SPEED MAGNETIC STIMULATOR
K
90
2607
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
K
90
3731
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K
89
4560
QSI 9000
K
90
0482
SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG
K
89
6567
CANTATA EMG/EVOKED RESPONSE SYSTEM
K
89
4608
MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM
K
89
0274
MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR
K
88
5246
ADVANTAGE
K
88
4870
TECA/MEDELEC 'CONCEPT' P420
K
88
3340
NEURAL MAGNETIC STIMULATOR, THE D190
K
88
1915
DANTEC MAGNETIC STIMULATOR
K
88
0088
CADWELL EXCEL
K
87
0567
EVOPORT 300
K
87
1964
SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
K
87
2106
DANTEC COUNTERPOINT
K
87
1338
NOVAMETRIX MODEL 200 MAGSTIM
K
86
3175
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
K
86
2690
TRAVELER LT
K
86
1900
LIFESCAN EVOKED POTENTIAL SYSTEM
K
86
0968
TM-3400, NOMAD (MODIFIED)
K
85
5232
SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
K
86
0903
TM-3600 A NEURODIAGNOSTIC SYSTEM
K
86
0240
CNS-EP SYSTEM AND EP 1.0 SOFTWARE
K
85
1300
NEUROPACK 8, MEE-4108
K
84
4992
BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
K
85
0109
NOMAD TM-3400
K
84
3815
EVOMATIC 8000/4000
K
84
4707
QUANTUM 84
K
84
3712
AUDIT TM V
K
84
2543
EVOKED POTENTIAL SYS
K
84
3464
SIEGEN NEUROSCOPE
K
84
3253
EMG/NCV & EVOKED RESPONSE, DESIGN W/
K
83
1896
COMPACT FOUR
K
83
0771
CADWELL 8400
K
82
2744
#ST10 PROGR. EVOKED RESPONSE STIMULATOR
K
82
2396
THE 3500
K
82
2214
CADWELL 7400
K
82
0908
TECA MODEL SENSOR ER 94
K
82
0414
UNIVERSAL TESTING & ANALYSIS SYSTEMS
K
81
1848
MODEL SIX BEAM SYSTEM
K
81
0482
SOMATOSENSORY STIMULATOR
K
81
0560
TN-3000 EVOKED RESPONSE SYSTEM
K
78
1704
STIMULATOR, TN-3001 SOMATOSENSORY
K
78
0539
STIMULATOR MODEL 8021
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
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
/
GWF
/
K862690
View Source
TRAVELER LT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862690
510(k) Type
Traditional
Applicant
BIO-LOGIC SYSTEMS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/1986
Days to Decision
133 days