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 Masimo Corporation.
40
Total
40
Cleared
152d
Avg days
1996
Since
40 devices
Cleared
Jan 15, 2004
EEG MONITOR WITH BIS, MODEL A-2000
Aspect Medical Systems, Inc.
Neurology
353d
Cleared
Aug 29, 2003
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
Aspect Medical Systems, Inc.
Neurology
88d
Cleared
Jan 13, 2003
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
Datex-Ohmeda
Neurology
90d
Cleared
Oct 04, 2002
PSA4000 EEG MONITOR WITH FRONTAL PSI
Physiometrix, Inc.
Neurology
217d
Cleared
Apr 22, 2002
SNAP EEG MONITOR
Nicolet Biomedical, Inc.
Neurology
90d
Cleared
Jan 10, 2002
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
Datex-Ohmeda
Neurology
90d
Cleared
Oct 01, 2001
BIS/EEG MODULE
General Electric Medical Systems Information Techn
Neurology
61d
Cleared
Jul 10, 2001
BIS ENGINE
Aspect Medical Systems, Inc.
Neurology
28d
Cleared
Jun 27, 2001
A-LINE AEP MONITOR
Alaris Medical Systems, Inc.
Neurology
86d
Cleared
Jun 15, 2001
EEG MIS MONITOR MODEL # A-2000
Aspect Medical Systems, Inc.
Neurology
28d
Cleared
Dec 15, 2000
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
Agilent Technologies Deutschland GmbH
Neurology
77d
Cleared
Sep 19, 2000
BIS ENGINE
Aspect Medical Systems, Inc.
Neurology
7d
Cleared
Jun 30, 2000
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
Physiometrix, Inc.
Neurology
88d
Cleared
Feb 06, 1998
A-2000 EEG MONITOR WITH BIS
Aspect Medical Systems, Inc.
Neurology
70d
Cleared
Feb 03, 1998
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
Spacelabs Medical, Inc.
Neurology
134d
Cleared
Oct 08, 1996
A-1000 EEG MONITOR AND A-1050 EEG MONITOR
Aspect Medical Systems, Inc.
Neurology
26d