GWN · Class II · 21 CFR 882.1460

FDA Product Code GWN: Nystagmograph

Leading manufacturers include Interacoustics A/S, Neuro Kinetics, Inc. and Bio-Logic Systems Corp..

60
Total
60
Cleared
151d
Avg days
1981
Since
60 devices
25–48 of 60
Cleared Feb 05, 2008
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254
Interacoustics A/S
Neurology · 175d
Cleared Sep 18, 2007
EYETRACKER/IDEAS
K070670
S.A. Instrumentation Difra
Neurology · 190d
Cleared Mar 30, 2007
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
K070729
Fall Prevention Technologies, LLC
Neurology · 15d
Cleared Oct 31, 2006
CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
K062015
Chronos Vision
Neurology · 106d
Cleared Jul 11, 2006
FOCUS VNG/ENG TYPE 1068
K061791
Gn Otometrics A/S
Neurology · 15d
Cleared May 23, 2005
DDAT OMT
K050098
Ddat(Uk), Ltd.
Neurology · 125d
Cleared Oct 06, 2004
BALANCEBACK VNG SYSTEM
K042529
Fall Prevention Technologies, LLC
Neurology · 19d
Cleared Dec 10, 2001
ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
K013060
Ics Medical
Neurology · 90d
Cleared Feb 27, 2001
ENGPLUS
K010059
Western Systems Research, Inc.
Neurology · 50d
Cleared Feb 01, 2001
EYETECT TREMOR MONITOR UNIT (TMU)
K003644
Eyetect, LLC
Neurology · 66d
Cleared Aug 12, 1999
EXPRESSEYE
K992473
Optomotor Laboratories
Neurology · 17d
Cleared Aug 03, 1999
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
K991642
Bertec Corp.
Neurology · 82d
Cleared Jul 28, 1999
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
K991497
Ics Medical Corp.
Neurology · 90d
Cleared Sep 11, 1998
ULMER (VNG) VIDEO NYSTAGMOGRAPH
K982103
Synapsys, Inc.
Neurology · 88d
Cleared Sep 22, 1997
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
K972631
Ics Medical Corp.
Neurology · 70d
Cleared Sep 10, 1997
2D VOG - VIDEO-OCULOGRAPHY
K972243
Sensomotoric Instruments, GmbH
Neurology · 86d
Cleared Jul 15, 1997
VISUALEYES: VIDEO EYE MONITOR
K964325
Micromedical Technologies, Inc.
Neurology · 258d
Cleared Jul 15, 1997
VIDEO EYE TRAKKER
K964646
Micromedical Technologies, Inc.
Neurology · 237d
Cleared Feb 03, 1995
VARIOUS ELECTRODES
K941928
Bio-Logic Systems Corp.
Neurology · 289d
Cleared Jun 10, 1992
JANUS ATAC ENG ANALYSIS SYSTEM
K904385
Life-Tech Intl., Inc.
Neurology · 625d
Cleared Apr 30, 1986
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457
Oxford Medilog, Inc.
Neurology · 84d
Cleared Nov 27, 1985
NYSTAGMOGRAPH EOG/ENG ANALYSES
K851190
Nicolet Biomedical Instruments
Neurology · 246d
Cleared Jul 22, 1985
ELECTRONYSTAGMOGRAPH (ENG RECORDER)
K850180
Bio-Logic Systems Corp.
Neurology · 186d
Cleared Dec 12, 1984
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
K842886
Teca, Inc.
Neurology · 142d