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Review Panel
Cardiovascular
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
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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
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
K
24
0593
VEEGix EEG System
2
Cleared 510(K)
K
22
0254
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
2
Cleared 510(K)
K
21
3299
Wireless EEG System
2
Cleared 510(K)
K
19
1322
E-EEGX, N-EEGX
2
Cleared 510(K)
K
19
2572
CNS Envision
2
Cleared 510(K)
K
19
0760
Cadwell Bolt Software
2
Cleared 510(K)
K
14
3487
Lifelines iEEG
2
Cleared 510(K)
K
14
2834
DiscoverEEG System, Model DE-401
2
Cleared 510(K)
K
13
3995
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
2
Cleared 510(K)
K
14
2064
GALILEO NT
2
Cleared 510(K)
K
14
1316
COGNISION EEG/EP SYSTEM
2
Cleared 510(K)
K
13
1882
GEODESICEEG SYSTEM 400 SERIES (GES 400)
2
Cleared 510(K)
K
12
3665
LIFELINES IEEG
2
Cleared 510(K)
K
09
1963
VIGILANT EEG MONITOR, VIGILANT 2.0
2
Cleared 510(K)
K
08
2886
ZOOM-100DC
2
Cleared 510(K)
K
08
0546
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
2
Cleared 510(K)
K
07
2382
MODEL I-2000 MONITOR
2
Cleared 510(K)
K
06
3797
GEODESIC EEG SYSTEM 300
2
Cleared 510(K)
K
06
2533
BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524
2
Cleared 510(K)
K
05
1883
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
2
Cleared 510(K)
K
03
3010
BRM2 BRAIN MONITOR
2
Cleared 510(K)
K
03
0489
BRM2 BRAIN MONITOR
2
Cleared 510(K)
K
02
3536
NUAMPS
2
Cleared 510(K)
K
00
1564
SCAN LT40 (40 CHANNELS)
2
Cleared 510(K)
K
00
1324
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
2
Cleared 510(K)
K
00
0892
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
2
Cleared 510(K)
K
00
0068
COMPUMEDICS E-SERIES EEG SYSTEM
2
Cleared 510(K)
K
99
1012
SIEMENS INFINITY EEG POD
2
Cleared 510(K)
K
98
2351
LUNA
2
Cleared 510(K)
K
95
5577
ECLIPSE VERSION 3.0
2
Cleared 510(K)
K
95
4157
DG PORTABLE SYSTEM
2
Cleared 510(K)
K
95
2347
A-1050 EEG MONITOR
2
Cleared 510(K)
K
95
3799
DG EXAMINER PLUS
2
Cleared 510(K)
K
95
1724
QUANTITATIVE EEG ANALYSIS SOFTWARE
2
Cleared 510(K)
K
94
0811
BRAINTRACE
2
Cleared 510(K)
K
91
5820
NEUROSEARCH-24 OR NRS-24
2
Cleared 510(K)
K
93
4050
TOPOGRAPHIC BRAIN MAPPING OPTION
2
Cleared 510(K)
K
92
3043
SPECTRAL EEG MONITOR MODEL A1000
2
Cleared 510(K)
K
91
3051
SPECTRAL EEG MONITOR MODEL B500
2
Cleared 510(K)
K
89
4889
TECA NEUROMAPPER 386
2
Cleared 510(K)
K
89
4088
TECA NEUROMAPPER 1620, BRAIN MAPPER
2
Cleared 510(K)
K
87
4733
GUARDIAN, EEG BRAIN MONITORING SYSTEM
2
Cleared 510(K)
K
86
3783
HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM
2
Cleared 510(K)
K
86
3650
QUANTIMAP III
2
Cleared 510(K)
K
86
0378
MIND MAP (20 CHANNEL EEG)
2
Cleared 510(K)
K
85
3420
CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS
2
Cleared 510(K)
K
85
2587
CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
2
Cleared 510(K)
K
85
0541
SLEEP STAGER
2
Cleared 510(K)
K
84
3808
DUAL CHENNEL BRAIN ACTIVITY MONITOR
2
Cleared 510(K)
K
84
1790
LIFESCAN EEG MONITOR
2
Cleared 510(K)
K
82
0653
OTE BIOMEDICA BERG FOURIER ANALYZER
2
Cleared 510(K)
K
81
0359
ELECTROENCEPHALOMYOGRAPH
2
Cleared 510(K)
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 30 November 2024 at 11:09 am
NE
/
subpart-b—neurological-diagnostic-devices
/
OLT
/
K033010
View Source
BRM2 BRAIN MONITOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033010
510(k) Type
Traditional
Applicant
BRAINZ INSTRUMENTS LTD.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
10/10/2003
Days to Decision
14 days
Submission Type
Summary
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
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
K
24
0593
VEEGix EEG System
K
22
0254
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K
21
3299
Wireless EEG System
K
19
1322
E-EEGX, N-EEGX
K
19
2572
CNS Envision
K
19
0760
Cadwell Bolt Software
K
14
3487
Lifelines iEEG
K
14
2834
DiscoverEEG System, Model DE-401
K
13
3995
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
K
14
2064
GALILEO NT
K
14
1316
COGNISION EEG/EP SYSTEM
K
13
1882
GEODESICEEG SYSTEM 400 SERIES (GES 400)
K
12
3665
LIFELINES IEEG
K
09
1963
VIGILANT EEG MONITOR, VIGILANT 2.0
K
08
2886
ZOOM-100DC
K
08
0546
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
K
07
2382
MODEL I-2000 MONITOR
K
06
3797
GEODESIC EEG SYSTEM 300
K
06
2533
BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524
K
05
1883
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
K
03
3010
BRM2 BRAIN MONITOR
K
03
0489
BRM2 BRAIN MONITOR
K
02
3536
NUAMPS
K
00
1564
SCAN LT40 (40 CHANNELS)
K
00
1324
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
K
00
0892
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
K
00
0068
COMPUMEDICS E-SERIES EEG SYSTEM
K
99
1012
SIEMENS INFINITY EEG POD
K
98
2351
LUNA
K
95
5577
ECLIPSE VERSION 3.0
K
95
4157
DG PORTABLE SYSTEM
K
95
2347
A-1050 EEG MONITOR
K
95
3799
DG EXAMINER PLUS
K
95
1724
QUANTITATIVE EEG ANALYSIS SOFTWARE
K
94
0811
BRAINTRACE
K
91
5820
NEUROSEARCH-24 OR NRS-24
K
93
4050
TOPOGRAPHIC BRAIN MAPPING OPTION
K
92
3043
SPECTRAL EEG MONITOR MODEL A1000
K
91
3051
SPECTRAL EEG MONITOR MODEL B500
K
89
4889
TECA NEUROMAPPER 386
K
89
4088
TECA NEUROMAPPER 1620, BRAIN MAPPER
K
87
4733
GUARDIAN, EEG BRAIN MONITORING SYSTEM
K
86
3783
HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM
K
86
3650
QUANTIMAP III
K
86
0378
MIND MAP (20 CHANNEL EEG)
K
85
3420
CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS
K
85
2587
CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
K
85
0541
SLEEP STAGER
K
84
3808
DUAL CHENNEL BRAIN ACTIVITY MONITOR
K
84
1790
LIFESCAN EEG MONITOR
K
82
0653
OTE BIOMEDICA BERG FOURIER ANALYZER
K
81
0359
ELECTROENCEPHALOMYOGRAPH
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
/
OLT
/
K033010
View Source
BRM2 BRAIN MONITOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033010
510(k) Type
Traditional
Applicant
BRAINZ INSTRUMENTS LTD.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
10/10/2003
Days to Decision
14 days
Submission Type
Summary