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
49–56 of 56
Cleared Aug 12, 1986
MIND MAP (20 CHANNEL EEG)
K860378
Mind Systems Corp.
Neurology · 190d
Cleared Feb 07, 1986
CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS
K853420
Alvar
Neurology · 177d
Cleared Aug 16, 1985
CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
K852587
Tracor Northern, Inc.
Neurology · 59d
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 Jul 12, 1984
LIFESCAN EEG MONITOR
K841790
Neurometrics
Neurology · 73d
Cleared May 07, 1982
OTE BIOMEDICA BERG FOURIER ANALYZER
K820653
Del Mar Avionics
Neurology · 59d
Cleared Mar 13, 1981
ELECTROENCEPHALOMYOGRAPH
K810359
Thoracel Research Labs.
Neurology · 31d