OLW · Class II · 21 CFR 882.1400

FDA Product Code OLW: Index-generating Electroencephalograph Software

Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.

Leading manufacturers include Aspect Medical Systems, Inc., Physiometrix, Inc. and Ge Healthcare.

40
Total
40
Cleared
152d
Avg days
1996
Since
40 devices
25–40 of 40
Cleared Jan 13, 2003
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459
Datex-Ohmeda
Neurology · 90d
Cleared Oct 04, 2002
PSA4000 EEG MONITOR WITH FRONTAL PSI
K020671
Physiometrix, Inc.
Neurology · 217d
Cleared Jan 10, 2002
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
K013389
Datex-Ohmeda
Neurology · 90d
Cleared Oct 01, 2001
BIS/EEG MODULE
K012466
General Electric Medical Systems Information Techn
Neurology · 61d
Cleared Jul 10, 2001
BIS ENGINE
K011834
Aspect Medical Systems, Inc.
Neurology · 28d
Cleared Jun 27, 2001
A-LINE AEP MONITOR
K010965
Alaris Medical Systems, Inc.
Neurology · 86d
Cleared Jun 15, 2001
EEG MIS MONITOR MODEL # A-2000
K011534
Aspect Medical Systems, Inc.
Neurology · 28d
Cleared Sep 19, 2000
BIS ENGINE
K002837
Aspect Medical Systems, Inc.
Neurology · 7d
Cleared Jun 30, 2000
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
K001069
Physiometrix, Inc.
Neurology · 88d
Cleared Feb 06, 1998
A-2000 EEG MONITOR WITH BIS
K974496
Aspect Medical Systems, Inc.
Neurology · 70d
Cleared Feb 03, 1998
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
K973596
Spacelabs Medical, Inc.
Neurology · 134d
Cleared Oct 08, 1996
A-1000 EEG MONITOR AND A-1050 EEG MONITOR
K963644
Aspect Medical Systems, Inc.
Neurology · 26d