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 Kvikna Ehf, Teca, Inc. and Aspect Medical Systems, Inc..

55
Total
55
Cleared
174d
Avg days
1981
Since
55 devices
25–48 of 55
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 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 Aug 02, 1985
SLEEP STAGER
K850541
Oxford Medilog, Inc.
Neurology · 172d
Cleared Nov 08, 1984
DUAL CHENNEL BRAIN ACTIVITY MONITOR
K843808
Datex Division Instrumentarium Corp.
Neurology · 42d
Cleared May 07, 1982
OTE BIOMEDICA BERG FOURIER ANALYZER
K820653
Del Mar Avionics
Neurology · 59d