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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
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Review Panel
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Review Panel
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Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
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Microbiology
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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
K
22
1471
E3 and Profile
2
Cleared 510(K)
K
21
2936
Vision Monitor- MonCvONE
2
Cleared 510(K)
K
21
1974
LED PHOTIC System
2
Cleared 510(K)
K
21
1643
Vision Monitor - MonpackONE
2
Cleared 510(K)
K
20
0705
Nurochek System
2
Cleared 510(K)
K
17
3936
Natus Photic Stimulator
2
Cleared 510(K)
K
14
2567
RETeval Visual Electrodiagnostic Device
2
Cleared 510(K)
K
11
3785
ADHERENT VISUAL STIMULATOR GOGGLES
2
Cleared 510(K)
K
12
0104
VISIONSEARCH 1
2
Cleared 510(K)
K
10
1763
DIOPSYS NOVA VEP VISION TESTING SYSTEM
2
Cleared 510(K)
K
10
1691
LIFELINES PHOTIC STIMULATOR
2
Cleared 510(K)
K
08
1591
NEUCODIA
2
Cleared 510(K)
K
04
3367
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
2
Cleared 510(K)
K
04
3491
ENFANTTM
2
Cleared 510(K)
K
02
3525
RETISCAN, RETIPORT
2
Cleared 510(K)
K
02
2304
ACCUMAP AUTOMATIC PERIMETER
2
Cleared 510(K)
K
01
1794
XLTEK LED GOGGLES, MODEL LED-01
2
Cleared 510(K)
K
00
1467
DA VINCHI EMG/EP ISA1004EP
2
Cleared 510(K)
K
99
1903
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
2
Cleared 510(K)
K
97
1214
KILOWIN
2
Cleared 510(K)
K
93
2571
TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4
2
Cleared 510(K)
K
90
3734
ADVANTAGE EP
2
Cleared 510(K)
K
88
3914
FATIGMETER
2
Cleared 510(K)
K
88
0593
TECA/MEDELEC MISTRAL
2
Cleared 510(K)
K
87
4136
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
2
Cleared 510(K)
K
87
2725
MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM
2
Cleared 510(K)
K
86
1069
TECA NEUROPTO WITH OS-5 STIMULATOR
2
Cleared 510(K)
K
86
0910
V100 VISUALLY EVOKED POTENTIAL MONITOR
2
Cleared 510(K)
K
86
0801
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
2
Cleared 510(K)
K
86
3956
MACULOSCOPE(TM)
2
Cleared 510(K)
K
85
4362
MODIFIED BRAIN ATLAS III
2
Cleared 510(K)
K
85
2533
L.E.D. GOGGLES, MODEL 580-LEDGOG
2
Cleared 510(K)
K
85
3412
WAVE GATE
2
Cleared 510(K)
K
84
4659
VPS 2250, CSU2250 & VFU 2250
2
Cleared 510(K)
K
84
4616
SIEGEN VISUAL STIMULATOR
2
Cleared 510(K)
K
84
2964
PHOTIC STIMULATOR TM-3030-70
2
Cleared 510(K)
K
84
2381
SLS 3500 LED VISUAL STIMULATOR
2
Cleared 510(K)
K
83
4442
LED STIMULATOR LS-05
2
Cleared 510(K)
K
83
1651
EVOKED POTENTIAL SYSTEM 2000
2
Cleared 510(K)
K
83
2084
EVOKED 3500 POTENTIAL SYSTEM
2
Cleared 510(K)
K
83
1047
BIOLOGIC SYSTEM BL 101
2
Cleared 510(K)
K
81
2061
MODEL S10VS VISUAL STIMULATOR
2
Cleared 510(K)
K
81
0481
VISUAL PATTERN REVERSAL GEN. & PHOTIC S.
2
Cleared 510(K)
K
80
1671
ESG-1 (EVOKED RESPONSE STIMULUS GENER)
2
Cleared 510(K)
K
79
1149
STIMULATOR MODEL SSS-1101
2
Cleared 510(K)
K
79
0570
STIMULATOR, NIC-106 VISUAL
2
Cleared 510(K)
K
79
0217
GENERATOR, MODEL VG-1
2
Cleared 510(K)
K
78
1461
MODEL 7320 VISUAL STIMULATOR
2
Cleared 510(K)
K
78
1398
TECA VS6 VIDEO STIMULATOR
2
Cleared 510(K)
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
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
/
GWE
/
K852533
View Source
L.E.D. GOGGLES, MODEL 580-LEDGOG
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852533
510(k) Type
Traditional
Applicant
BIO-LOGIC SYSTEMS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/12/1985
Days to Decision
181 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
K
22
1471
E3 and Profile
K
21
2936
Vision Monitor- MonCvONE
K
21
1974
LED PHOTIC System
K
21
1643
Vision Monitor - MonpackONE
K
20
0705
Nurochek System
K
17
3936
Natus Photic Stimulator
K
14
2567
RETeval Visual Electrodiagnostic Device
K
11
3785
ADHERENT VISUAL STIMULATOR GOGGLES
K
12
0104
VISIONSEARCH 1
K
10
1763
DIOPSYS NOVA VEP VISION TESTING SYSTEM
K
10
1691
LIFELINES PHOTIC STIMULATOR
K
08
1591
NEUCODIA
K
04
3367
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
K
04
3491
ENFANTTM
K
02
3525
RETISCAN, RETIPORT
K
02
2304
ACCUMAP AUTOMATIC PERIMETER
K
01
1794
XLTEK LED GOGGLES, MODEL LED-01
K
00
1467
DA VINCHI EMG/EP ISA1004EP
K
99
1903
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
K
97
1214
KILOWIN
K
93
2571
TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4
K
90
3734
ADVANTAGE EP
K
88
3914
FATIGMETER
K
88
0593
TECA/MEDELEC MISTRAL
K
87
4136
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
K
87
2725
MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM
K
86
1069
TECA NEUROPTO WITH OS-5 STIMULATOR
K
86
0910
V100 VISUALLY EVOKED POTENTIAL MONITOR
K
86
0801
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
K
86
3956
MACULOSCOPE(TM)
K
85
4362
MODIFIED BRAIN ATLAS III
K
85
2533
L.E.D. GOGGLES, MODEL 580-LEDGOG
K
85
3412
WAVE GATE
K
84
4659
VPS 2250, CSU2250 & VFU 2250
K
84
4616
SIEGEN VISUAL STIMULATOR
K
84
2964
PHOTIC STIMULATOR TM-3030-70
K
84
2381
SLS 3500 LED VISUAL STIMULATOR
K
83
4442
LED STIMULATOR LS-05
K
83
1651
EVOKED POTENTIAL SYSTEM 2000
K
83
2084
EVOKED 3500 POTENTIAL SYSTEM
K
83
1047
BIOLOGIC SYSTEM BL 101
K
81
2061
MODEL S10VS VISUAL STIMULATOR
K
81
0481
VISUAL PATTERN REVERSAL GEN. & PHOTIC S.
K
80
1671
ESG-1 (EVOKED RESPONSE STIMULUS GENER)
K
79
1149
STIMULATOR MODEL SSS-1101
K
79
0570
STIMULATOR, NIC-106 VISUAL
K
79
0217
GENERATOR, MODEL VG-1
K
78
1461
MODEL 7320 VISUAL STIMULATOR
K
78
1398
TECA VS6 VIDEO STIMULATOR
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
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
/
GWE
/
K852533
View Source
L.E.D. GOGGLES, MODEL 580-LEDGOG
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852533
510(k) Type
Traditional
Applicant
BIO-LOGIC SYSTEMS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/12/1985
Days to Decision
181 days