OLT · Class II · 21 CFR 882.1400

FDA Product Code OLT: Non-normalizing Quantitative Electroencephalograph Software

Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.

Leading manufacturers include Medelec , Ltd., Kvikna Ehf and Stellate Systems.

56
Total
56
Cleared
173d
Avg days
1981
Since
56 devices
25–48 of 56
Cleared Oct 10, 2003
BRM2 BRAIN MONITOR
K033010
Brainz Instruments , Ltd.
Neurology · 14d
Cleared May 02, 2003
BRM2 BRAIN MONITOR
K030489
Brainz Instruments , Ltd.
Neurology · 77d
Cleared Jan 15, 2003
NUAMPS
K023536
Neuroscan
Neurology · 86d
Cleared Nov 24, 2000
SCAN LT40 (40 CHANNELS)
K001564
Neuro Scan Labs
Neurology · 189d
Cleared Jul 11, 2000
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
K001324
Neuro Scan Labs
Neurology · 76d
Cleared Jun 16, 2000
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
K000892
Datex-Ohmeda, Inc.
Neurology · 88d
Cleared Mar 13, 2000
COMPUMEDICS E-SERIES EEG SYSTEM
K000068
Compumedics Neuro Science Pty , Ltd.
Neurology · 63d
Cleared Jun 24, 1999
SIEMENS INFINITY EEG POD
K991012
Siemens Medical Solutions USA, Inc.
Neurology · 90d
Cleared Jul 29, 1998
LUNA
K982351
Stellate Systems
Neurology · 23d
Cleared Sep 20, 1996
ECLIPSE VERSION 3.0
K955577
Stellate Systems
Neurology · 317d
Cleared Jan 17, 1996
DG PORTABLE SYSTEM
K954157
Medelec , Ltd.
Neurology · 134d
Cleared Jan 16, 1996
A-1050 EEG MONITOR
K952347
Aspect Medical Systems, Inc.
Neurology · 242d
Cleared Nov 08, 1995
DG EXAMINER PLUS
K953799
Medelec , Ltd.
Neurology · 86d
Cleared Jul 14, 1995
QUANTITATIVE EEG ANALYSIS SOFTWARE
K951724
Neuroconcepts, Inc.
Neurology · 91d
Cleared May 02, 1995
BRAINTRACE
K940811
Brainstorms Monitoring Corp.
Neurology · 434d
Cleared Feb 08, 1995
NEUROSEARCH-24 OR NRS-24
K915820
Lexicor Medical Technology, Inc.
Neurology · 1136d
Cleared Feb 03, 1994
TOPOGRAPHIC BRAIN MAPPING OPTION
K934050
Biosound, Inc.
Neurology · 168d
Cleared Dec 03, 1992
SPECTRAL EEG MONITOR MODEL A1000
K923043
Aspect Medical Systems, Inc.
Neurology · 162d
Cleared Aug 20, 1991
SPECTRAL EEG MONITOR MODEL B500
K913051
Biometrak Corp.
Neurology · 42d
Cleared Dec 22, 1989
TECA NEUROMAPPER 386
K894889
Teca, Inc.
Neurology · 143d
Cleared Nov 15, 1989
TECA NEUROMAPPER 1620, BRAIN MAPPER
K894088
Teca, Inc.
Neurology · 160d
Cleared Feb 29, 1988
GUARDIAN, EEG BRAIN MONITORING SYSTEM
K874733
Tracor Northern, Inc.
Neurology · 103d
Cleared Mar 03, 1987
HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM
K863783
Hzi Research Center
Neurology · 158d
Cleared Sep 26, 1986
QUANTIMAP III
K863650
Quantified Signal Imaging, Inc.
Neurology · 8d