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
K
23
3649
ALGO Pro Newborn Hearing Screener (ALGO Pro)
2
Cleared 510(K)
K
22
0139
QScreen
2
Cleared 510(K)
K
21
1147
ALGO 7i
2
Cleared 510(K)
K
19
3033
GSI Audera Pro
2
Cleared 510(K)
K
16
3326
SmartEP
2
Cleared 510(K)
K
16
2037
Eclipse with VEMP
2
Cleared 510(K)
K
14
3670
ICS CHARTR EP 200 WITH VEMP
2
Cleared 510(K)
K
14
1446
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
2
Cleared 510(K)
K
13
2957
MADSEN ACCUSCREEN TYPE 1077
2
Cleared 510(K)
K
13
1141
EARPROBE
2
Cleared 510(K)
K
12
3701
HEARLAB ACA
2
Cleared 510(K)
K
12
2067
TYPE 1077 ACCUSCREEN
2
Cleared 510(K)
K
11
1555
CIRCUMAURAL ADHESIVE REPLACEMENT
2
Cleared 510(K)
K
10
3760
TITAN
2
Cleared 510(K)
K
10
0661
EARPROBE
2
Cleared 510(K)
K
09
2373
ICS CHARTR EP 200
2
Cleared 510(K)
K
09
0579
SMARTSCREENER-PLUS2
2
Cleared 510(K)
K
08
3399
ICS CHARTR EP 200
2
Cleared 510(K)
K
08
2035
MAICO MB 11 WITH BERAPHONE PROBE
2
Cleared 510(K)
K
08
0060
VIVOSONIC NEUROSCREEN
2
Cleared 510(K)
K
07
3384
SMART COUPLER, MODEL M015401
2
Cleared 510(K)
K
07
3626
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
2
Cleared 510(K)
K
07
3665
ALGO 5 NEWBORN HEARING SCREENER
2
Cleared 510(K)
K
07
0608
SMARTEP, MODEL M010000
2
Cleared 510(K)
K
07
0696
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
2
Cleared 510(K)
K
06
1443
SMART USBLITE, MODEL M011120
2
Cleared 510(K)
K
04
3396
INTEGRITY, MODEL V500
2
Cleared 510(K)
K
03
1051
SMARTEP-ASSR, MODEL M811007
2
Cleared 510(K)
K
03
0907
STACKED ABR FOR NAVIGATOR PRO
2
Cleared 510(K)
K
03
1009
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
2
Cleared 510(K)
K
03
0823
ALGO 3I NEWBORN HEARING SCREENER
2
Cleared 510(K)
K
02
1895
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
2
Cleared 510(K)
K
01
3977
ECHO-SCREEN T, TA, TD, TDA, TC
2
Cleared 510(K)
K
02
1215
BIO-LOGIC ABAER CUB
2
Cleared 510(K)
K
01
1842
SABRE COMPAC
2
Cleared 510(K)
K
01
2415
AURIS AEP
2
Cleared 510(K)
K
01
3137
ALGO 3 NEWBORN HEARING SCREENER
2
Cleared 510(K)
K
01
1746
MB 11
2
Cleared 510(K)
K
00
2985
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
2
Cleared 510(K)
K
99
4149
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
2
Cleared 510(K)
K
99
3177
SABRE
2
Cleared 510(K)
K
99
1853
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
2
Cleared 510(K)
K
99
2807
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
2
Cleared 510(K)
K
97
2157
EXCEL AV STIM 1000
2
Cleared 510(K)
K
96
0097
CHARTR EP
2
Cleared 510(K)
K
95
3732
TECA PREMIERE
2
Cleared 510(K)
K
95
2080
CLARITY SYSTEM II
2
Cleared 510(K)
K
93
6039
ALGO-2 NEWBORN HEARING SCREENER
2
Cleared 510(K)
K
92
5648
SMART-SCREENER (AUDITORY)
2
Cleared 510(K)
K
92
6574
MODEL 330 SCREENING AUDIO METER, MODIFIED
2
Cleared 510(K)
K
91
3957
DANTEC COUNTERPOINT MK2(TM)
2
Cleared 510(K)
K
91
3785
CORONET 100
2
Cleared 510(K)
K
90
4926
SMART-EP
2
Cleared 510(K)
K
90
5632
NICOLET MAPLELEAF SYSTEM
2
Cleared 510(K)
K
87
4193
MICROSHEV MODEL 2000
2
Cleared 510(K)
K
87
0030
THE SCREENER GSI 55 ABR SCREENER
2
Cleared 510(K)
K
86
2906
TECA/MEDELEC AS-10 SENSOR
2
Cleared 510(K)
K
86
3156
TECA/MEDELEC AUDIOSTAR
2
Cleared 510(K)
K
86
3985
EVOPORT 100
2
Cleared 510(K)
K
86
2430
SIEGEN HEADPHONES
2
Cleared 510(K)
K
86
2361
40-HZ AUDITORY EVOKED RESPONSE TEST
2
Cleared 510(K)
K
86
2363
INSERT EARPHONES
2
Cleared 510(K)
K
85
2687
ALGO I
2
Cleared 510(K)
K
83
2510
EVOKED POTENTIALS SYSTEM MK10
2
Cleared 510(K)
K
83
0579
MULTI-SIGNAL AUDITORY STIMULATOR SM700
2
Cleared 510(K)
K
82
2177
AUDIOMETERS (VARIOUS MODELS)
2
Cleared 510(K)
K
81
3009
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
2
Cleared 510(K)
K
81
0473
MK6 ERA SYSTEM
2
Cleared 510(K)
K
81
0138
SYNAP-I INFANT SENSORY ASSESSMENT UNIT
2
Cleared 510(K)
K
81
0539
MODEL S10CTCM AUDITORY STIMULATOR
2
Cleared 510(K)
K
79
2085
C-ERA-100 COMPUTERIZED ELECTRIC RESPON
2
Cleared 510(K)
K
78
1667
AMPLAID MARK 4 AND MARK 5
2
Cleared 510(K)
K
78
0540
ELECTRIC RESPONSE AUDIOMETER
2
Cleared 510(K)
K
77
0878
SIGNAL PROCESSOR/AVERAGER MODEL 7S11
2
Cleared 510(K)
K
77
0268
SYS. FOR REC. BSER RESPONSES
2
Cleared 510(K)
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 30 November 2024 at 11:09 am
NE
/
subpart-b—neurological-diagnostic-devices
/
GWJ
/
K993177
View Source
SABRE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K993177
510(k) Type
Traditional
Applicant
SLE LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/16/1999
Days to Decision
85 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
K
23
3649
ALGO Pro Newborn Hearing Screener (ALGO Pro)
K
22
0139
QScreen
K
21
1147
ALGO 7i
K
19
3033
GSI Audera Pro
K
16
3326
SmartEP
K
16
2037
Eclipse with VEMP
K
14
3670
ICS CHARTR EP 200 WITH VEMP
K
14
1446
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
K
13
2957
MADSEN ACCUSCREEN TYPE 1077
K
13
1141
EARPROBE
K
12
3701
HEARLAB ACA
K
12
2067
TYPE 1077 ACCUSCREEN
K
11
1555
CIRCUMAURAL ADHESIVE REPLACEMENT
K
10
3760
TITAN
K
10
0661
EARPROBE
K
09
2373
ICS CHARTR EP 200
K
09
0579
SMARTSCREENER-PLUS2
K
08
3399
ICS CHARTR EP 200
K
08
2035
MAICO MB 11 WITH BERAPHONE PROBE
K
08
0060
VIVOSONIC NEUROSCREEN
K
07
3384
SMART COUPLER, MODEL M015401
K
07
3626
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K
07
3665
ALGO 5 NEWBORN HEARING SCREENER
K
07
0608
SMARTEP, MODEL M010000
K
07
0696
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
K
06
1443
SMART USBLITE, MODEL M011120
K
04
3396
INTEGRITY, MODEL V500
K
03
1051
SMARTEP-ASSR, MODEL M811007
K
03
0907
STACKED ABR FOR NAVIGATOR PRO
K
03
1009
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K
03
0823
ALGO 3I NEWBORN HEARING SCREENER
K
02
1895
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K
01
3977
ECHO-SCREEN T, TA, TD, TDA, TC
K
02
1215
BIO-LOGIC ABAER CUB
K
01
1842
SABRE COMPAC
K
01
2415
AURIS AEP
K
01
3137
ALGO 3 NEWBORN HEARING SCREENER
K
01
1746
MB 11
K
00
2985
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
K
99
4149
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K
99
3177
SABRE
K
99
1853
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
K
99
2807
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
K
97
2157
EXCEL AV STIM 1000
K
96
0097
CHARTR EP
K
95
3732
TECA PREMIERE
K
95
2080
CLARITY SYSTEM II
K
93
6039
ALGO-2 NEWBORN HEARING SCREENER
K
92
5648
SMART-SCREENER (AUDITORY)
K
92
6574
MODEL 330 SCREENING AUDIO METER, MODIFIED
K
91
3957
DANTEC COUNTERPOINT MK2(TM)
K
91
3785
CORONET 100
K
90
4926
SMART-EP
K
90
5632
NICOLET MAPLELEAF SYSTEM
K
87
4193
MICROSHEV MODEL 2000
K
87
0030
THE SCREENER GSI 55 ABR SCREENER
K
86
2906
TECA/MEDELEC AS-10 SENSOR
K
86
3156
TECA/MEDELEC AUDIOSTAR
K
86
3985
EVOPORT 100
K
86
2430
SIEGEN HEADPHONES
K
86
2361
40-HZ AUDITORY EVOKED RESPONSE TEST
K
86
2363
INSERT EARPHONES
K
85
2687
ALGO I
K
83
2510
EVOKED POTENTIALS SYSTEM MK10
K
83
0579
MULTI-SIGNAL AUDITORY STIMULATOR SM700
K
82
2177
AUDIOMETERS (VARIOUS MODELS)
K
81
3009
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
K
81
0473
MK6 ERA SYSTEM
K
81
0138
SYNAP-I INFANT SENSORY ASSESSMENT UNIT
K
81
0539
MODEL S10CTCM AUDITORY STIMULATOR
K
79
2085
C-ERA-100 COMPUTERIZED ELECTRIC RESPON
K
78
1667
AMPLAID MARK 4 AND MARK 5
K
78
0540
ELECTRIC RESPONSE AUDIOMETER
K
77
0878
SIGNAL PROCESSOR/AVERAGER MODEL 7S11
K
77
0268
SYS. FOR REC. BSER RESPONSES
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
/
GWJ
/
K993177
View Source
SABRE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K993177
510(k) Type
Traditional
Applicant
SLE LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/16/1999
Days to Decision
85 days
Submission Type
Summary