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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
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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
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
K
24
2305
BE Plus PRO, Neurotravel LIGHT
2
Cleared 510(K)
K
24
0646
DreamClear
2
Cleared 510(K)
K
23
2210
X-trodes System M
2
Cleared 510(K)
K
23
0148
Vlab
2
Cleared 510(K)
K
22
3676
SomniCheck
2
Cleared 510(K)
K
22
0631
NomadAir PMU810
2
Cleared 510(K)
K
20
3331
Quick-20m
2
Cleared 510(K)
K
20
2174
Digital NeuroPort Biopotential Signal Processing System
2
Cleared 510(K)
K
20
1747
8-CH Electroencephalography Amplifier
2
Cleared 510(K)
K
17
2312
eego amplifiers
2
Cleared 510(K)
K
17
1397
Sienna Ultimate Wireless Amplifier
2
Cleared 510(K)
K
17
1669
g.Nautilus PRO
2
Cleared 510(K)
K
15
1600
R-40 EEG Amplifier
2
Cleared 510(K)
K
13
3517
NEMUS 2 SYSTEM
2
Cleared 510(K)
K
12
3255
g.HIamp
2
Cleared 510(K)
K
12
1996
BE PLUS LTM AMPLIFIER GWI AMPLIFIER
2
Cleared 510(K)
K
10
3140
NICOLET WIRELESS EEG
2
Cleared 510(K)
K
09
2699
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
2
Cleared 510(K)
K
09
0957
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
2
Cleared 510(K)
K
08
3322
NEUROMETRIX BIOAMPLIFIER
2
Cleared 510(K)
K
06
3599
PORTI 7 PHYSIOLOGICAL AMPLIFIER
2
Cleared 510(K)
K
06
0374
REFA, PHYSIOLOGICAL AMPLIFIER
2
Cleared 510(K)
K
06
0803
G.USBAMP
2
Cleared 510(K)
K
05
3606
BE PLUS / AURA-LTM64 AMPLIFIER
2
Cleared 510(K)
K
05
1852
SINGLE AMPLIFIER FOR BOTOX
2
Cleared 510(K)
K
05
2060
OPTI-AMP DC-POWERED
2
Cleared 510(K)
K
04
1198
NIC36 AMPLIFIER
2
Cleared 510(K)
K
04
0113
SANDMAN SD20 AMPLIFIER
2
Cleared 510(K)
K
00
3154
MIZAR, BASIS BE, SANDMAN DIGITAL
2
Cleared 510(K)
K
97
2515
SENSOR AMPLIFIER
2
Cleared 510(K)
K
96
3669
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
2
Cleared 510(K)
K
94
3673
MMC AMPLIFIER
2
Cleared 510(K)
K
91
4876
OPTI-AMP
2
Cleared 510(K)
K
91
2436
AM-PAK
2
Cleared 510(K)
K
90
1797
THE WONDER BOX
2
Cleared 510(K)
K
90
4222
VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
2
Cleared 510(K)
K
90
0063
MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)
2
Cleared 510(K)
K
88
4071
AMPLAID EMG15
2
Cleared 510(K)
K
88
1177
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
2
Cleared 510(K)
K
88
0773
THE VENUS SYSTEM
2
Cleared 510(K)
K
87
0794
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
2
Cleared 510(K)
K
87
1678
NICOLET AMP 6R11 SYSTEM
2
Cleared 510(K)
K
86
0289
PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER
2
Cleared 510(K)
K
86
1014
AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)
2
Cleared 510(K)
K
84
1612
NEUROPACK II 5100
2
Cleared 510(K)
K
83
3413
COMPUTERSCOPE CPS-ABR
2
Cleared 510(K)
K
82
1250
METRACO EVOKED POTENTIAL SYSTEM
2
Cleared 510(K)
K
78
1743
RESPONSE SYSTEM, TN-3000
2
Cleared 510(K)
K
78
1289
PREAMPLIFIER MODEL 113
2
Cleared 510(K)
K
77
2102
AMPLIFIER OTRONA, MODEL N3A-EMG
2
Cleared 510(K)
K
77
1683
AMPLIFIER MODEL N3B-EEG
2
Cleared 510(K)
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 30 November 2024 at 11:09 am
NE
/
subpart-b—neurological-diagnostic-devices
/
GWL
/
K123255
View Source
g.HIamp
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123255
510(k) Type
Traditional
Applicant
G.TEC MEDICAL ENGINEERING GMBH
Country
Austria
FDA Decision
Substantially Equivalent
Decision Date
12/20/2012
Days to Decision
63 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
K
24
2305
BE Plus PRO, Neurotravel LIGHT
K
24
0646
DreamClear
K
23
2210
X-trodes System M
K
23
0148
Vlab
K
22
3676
SomniCheck
K
22
0631
NomadAir PMU810
K
20
3331
Quick-20m
K
20
2174
Digital NeuroPort Biopotential Signal Processing System
K
20
1747
8-CH Electroencephalography Amplifier
K
17
2312
eego amplifiers
K
17
1397
Sienna Ultimate Wireless Amplifier
K
17
1669
g.Nautilus PRO
K
15
1600
R-40 EEG Amplifier
K
13
3517
NEMUS 2 SYSTEM
K
12
3255
g.HIamp
K
12
1996
BE PLUS LTM AMPLIFIER GWI AMPLIFIER
K
10
3140
NICOLET WIRELESS EEG
K
09
2699
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
K
09
0957
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
K
08
3322
NEUROMETRIX BIOAMPLIFIER
K
06
3599
PORTI 7 PHYSIOLOGICAL AMPLIFIER
K
06
0374
REFA, PHYSIOLOGICAL AMPLIFIER
K
06
0803
G.USBAMP
K
05
3606
BE PLUS / AURA-LTM64 AMPLIFIER
K
05
1852
SINGLE AMPLIFIER FOR BOTOX
K
05
2060
OPTI-AMP DC-POWERED
K
04
1198
NIC36 AMPLIFIER
K
04
0113
SANDMAN SD20 AMPLIFIER
K
00
3154
MIZAR, BASIS BE, SANDMAN DIGITAL
K
97
2515
SENSOR AMPLIFIER
K
96
3669
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
K
94
3673
MMC AMPLIFIER
K
91
4876
OPTI-AMP
K
91
2436
AM-PAK
K
90
1797
THE WONDER BOX
K
90
4222
VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
K
90
0063
MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)
K
88
4071
AMPLAID EMG15
K
88
1177
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K
88
0773
THE VENUS SYSTEM
K
87
0794
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K
87
1678
NICOLET AMP 6R11 SYSTEM
K
86
0289
PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER
K
86
1014
AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)
K
84
1612
NEUROPACK II 5100
K
83
3413
COMPUTERSCOPE CPS-ABR
K
82
1250
METRACO EVOKED POTENTIAL SYSTEM
K
78
1743
RESPONSE SYSTEM, TN-3000
K
78
1289
PREAMPLIFIER MODEL 113
K
77
2102
AMPLIFIER OTRONA, MODEL N3A-EMG
K
77
1683
AMPLIFIER MODEL N3B-EEG
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
/
GWL
/
K123255
View Source
g.HIamp
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123255
510(k) Type
Traditional
Applicant
G.TEC MEDICAL ENGINEERING GMBH
Country
Austria
FDA Decision
Substantially Equivalent
Decision Date
12/20/2012
Days to Decision
63 days
Submission Type
Summary