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
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
K
21
3007
Cerebra Sleep System
2
Cleared 510(K)
K
20
1054
SOMNOscreen plus
2
Cleared 510(K)
K
19
2624
ApneaTrak
2
Cleared 510(K)
K
18
1709
Serenity Piezo Sensor, Serenity Thermocouple Sensor
2
Cleared 510(K)
K
17
3868
Serenity Body Position Sensor, Serenity RIP Sensors
2
Cleared 510(K)
K
17
3690
Grass TWin
2
Cleared 510(K)
K
17
2986
Zmachine Synergy
2
Cleared 510(K)
K
17
2711
Comet-PLUS
2
Cleared 510(K)
K
16
1650
Polysmith Sleep System, Model NTI7593
2
Cleared 510(K)
K
14
2774
Polysmith Sleep System
2
Cleared 510(K)
K
13
1415
LIVE VIEW PANEL (LVP)
2
Cleared 510(K)
K
11
1055
GALAXY SYSTEM; JUPITER
2
Cleared 510(K)
K
10
1830
ZMACHINE, MODEL DT-100
2
Cleared 510(K)
K
09
3728
BE MICRO, TREA
2
Cleared 510(K)
K
07
3491
EEG-1100A SWITCH BOX
2
Cleared 510(K)
K
07
1782
MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES
2
Cleared 510(K)
K
05
0425
AURA-PSG
2
Cleared 510(K)
K
05
2066
CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
2
Cleared 510(K)
K
05
0833
ELECTRODE JUNCTION BOX, MODEL JE-921A
2
Cleared 510(K)
K
05
0143
OMNIPRO SYSTEM
2
Cleared 510(K)
K
04
2039
FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
2
Cleared 510(K)
K
04
2364
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
2
Cleared 510(K)
K
03
3475
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
2
Cleared 510(K)
K
03
1202
MEDIPALM-20
2
Cleared 510(K)
K
02
2249
NIGHTRON POLYSOMNOGRAPHY SYSTEM
2
Cleared 510(K)
K
02
2037
XLTEK SLEEP SYSTEM
2
Cleared 510(K)
K
02
1807
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
2
Cleared 510(K)
K
02
2121
PSG INPUT BOX, MODEL JE-912AK
2
Cleared 510(K)
K
02
1185
NERVUS MONITOR
2
Cleared 510(K)
K
01
2976
TWIN PLUS
2
Cleared 510(K)
K
01
3450
NOTTA AMBULATORY RECORDER
2
Cleared 510(K)
K
01
2085
SOMNO STAR & SERIES SLEEP SYSTEM
2
Cleared 510(K)
K
01
0728
HARMONE-SCHWARZER EEG SYSTEM
2
Cleared 510(K)
K
01
0460
LIFELINES TRACKIT
2
Cleared 510(K)
K
01
1204
NEUROFAX, MODELS EEG-1100A, EEG-9100A
2
Cleared 510(K)
K
00
3175
COMPUMEDICS SIESTA SYSTEM
2
Cleared 510(K)
K
00
3681
BIO-LOGIC SLEEPSCAN NETLINK
2
Cleared 510(K)
K
00
1013
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
2
Cleared 510(K)
K
00
0338
VITAPORT 3
2
Cleared 510(K)
K
99
4142
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
2
Cleared 510(K)
K
99
2742
NEUROFAX, MODEL EEG-1100A
2
Cleared 510(K)
K
99
2283
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
2
Cleared 510(K)
K
99
2291
H20- TETHERED OPTION
2
Cleared 510(K)
K
99
1446
BIOSACA SYSTEM, MODEL 800
2
Cleared 510(K)
K
99
1900
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
2
Cleared 510(K)
K
99
0522
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
2
Cleared 510(K)
K
98
4580
BIOSACA SYSTEM
2
Cleared 510(K)
K
98
3072
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
2
Cleared 510(K)
K
98
3913
MODIFICATION TO BIO-LOGIC SLEEPSCAN
2
Cleared 510(K)
K
97
4583
DEEGLITE
2
Cleared 510(K)
K
97
4587
H2O
2
Cleared 510(K)
K
97
1813
EMBLA
2
Cleared 510(K)
K
97
1867
ALICE 4R SYSTEM
2
Cleared 510(K)
K
97
0951
GRASS BRAINWAVE SOFTWARE
2
Cleared 510(K)
K
96
1638
MEDILOG MPA-S
2
Cleared 510(K)
K
92
2106
ALICE
2
Cleared 510(K)
K
93
4599
SANDMAN
2
Cleared 510(K)
K
86
0458
ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.
2
Cleared 510(K)
K
85
4665
4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
2
Cleared 510(K)
K
86
0219
SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM
2
Cleared 510(K)
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
/
OLV
/
K974583
View Source
DEEGLITE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974583
510(k) Type
Traditional
Applicant
GRASS-TELEFACTOR PRODUCT GROUP
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/9/1998
Days to Decision
203 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
OLU
Normalizing Quantitative Electroencephalograph Software
OLV
Standard Polysomnograph With Electroencephalograph
K
21
3007
Cerebra Sleep System
K
20
1054
SOMNOscreen plus
K
19
2624
ApneaTrak
K
18
1709
Serenity Piezo Sensor, Serenity Thermocouple Sensor
K
17
3868
Serenity Body Position Sensor, Serenity RIP Sensors
K
17
3690
Grass TWin
K
17
2986
Zmachine Synergy
K
17
2711
Comet-PLUS
K
16
1650
Polysmith Sleep System, Model NTI7593
K
14
2774
Polysmith Sleep System
K
13
1415
LIVE VIEW PANEL (LVP)
K
11
1055
GALAXY SYSTEM; JUPITER
K
10
1830
ZMACHINE, MODEL DT-100
K
09
3728
BE MICRO, TREA
K
07
3491
EEG-1100A SWITCH BOX
K
07
1782
MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES
K
05
0425
AURA-PSG
K
05
2066
CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
K
05
0833
ELECTRODE JUNCTION BOX, MODEL JE-921A
K
05
0143
OMNIPRO SYSTEM
K
04
2039
FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
K
04
2364
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
K
03
3475
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
K
03
1202
MEDIPALM-20
K
02
2249
NIGHTRON POLYSOMNOGRAPHY SYSTEM
K
02
2037
XLTEK SLEEP SYSTEM
K
02
1807
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
K
02
2121
PSG INPUT BOX, MODEL JE-912AK
K
02
1185
NERVUS MONITOR
K
01
2976
TWIN PLUS
K
01
3450
NOTTA AMBULATORY RECORDER
K
01
2085
SOMNO STAR & SERIES SLEEP SYSTEM
K
01
0728
HARMONE-SCHWARZER EEG SYSTEM
K
01
0460
LIFELINES TRACKIT
K
01
1204
NEUROFAX, MODELS EEG-1100A, EEG-9100A
K
00
3175
COMPUMEDICS SIESTA SYSTEM
K
00
3681
BIO-LOGIC SLEEPSCAN NETLINK
K
00
1013
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K
00
0338
VITAPORT 3
K
99
4142
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
K
99
2742
NEUROFAX, MODEL EEG-1100A
K
99
2283
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K
99
2291
H20- TETHERED OPTION
K
99
1446
BIOSACA SYSTEM, MODEL 800
K
99
1900
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
K
99
0522
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
K
98
4580
BIOSACA SYSTEM
K
98
3072
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K
98
3913
MODIFICATION TO BIO-LOGIC SLEEPSCAN
K
97
4583
DEEGLITE
K
97
4587
H2O
K
97
1813
EMBLA
K
97
1867
ALICE 4R SYSTEM
K
97
0951
GRASS BRAINWAVE SOFTWARE
K
96
1638
MEDILOG MPA-S
K
92
2106
ALICE
K
93
4599
SANDMAN
K
86
0458
ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.
K
85
4665
4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
K
86
0219
SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM
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
/
OLV
/
K974583
View Source
DEEGLITE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974583
510(k) Type
Traditional
Applicant
GRASS-TELEFACTOR PRODUCT GROUP
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/9/1998
Days to Decision
203 days
Submission Type
Summary